System and method of manufacturing a medical implant

ABSTRACT

A system and method for forming a medical implant using a printing device. The printing device includes a print head having a heated nozzle, a heated build plate for receiving the printed material thereon, and a reflective plate having an active heater. A method for forming a medical device includes extruding a printing material by contiguous deposition to form a porous object having a lattice-like structure. The medical device, such as a spinal implant, may have interconnected pores and different regions, each having a different porosity for encouraging bone growth therein. The printed medical implant may be designed to be patient-specific, customized, and printed on-demand.

RELATED APPLICATIONS

This patent application is a continuation application claiming prioritybenefit, with regard to all common subject matter, of U.S. patentapplication Ser. No. 17/226,200, filed Apr. 9, 2021, entitled “SYSTEMAND METHOD OF MANUFACTURING A MEDICAL IMPLANT.” The identifiedearlier-filed patent application is hereby incorporated by reference inits entirety into the present application.

BACKGROUND 1. Field

Embodiments of the invention relate to a method, system and printingdevice for printing a customized object, such as a medical implant. Morespecifically, embodiments of the invention relate to a method, system,and printing device for forming a surgical implant of a polymericmaterial.

2. Related Art

What is needed is a process for manufacturing a medical implant of apolymeric material that allows for customizing at least the size, shape,and porosity thereof.

The invention describes an improved method and system for manufacturinga surgical device, such as a spinal implant or other medical implant.

The invention describes a printing device for three-dimensional printingthat can be programmed to create a custom medical device. The printingdevice is configured to allow the printing material to be a polymericmaterial, such as polyaryletherketone (PAEK), or more specificallypolyether ether ketone (PEEK).

Prior printing devices were not capable of adequately maintaining theprinting material at an optimized temperature during the entire printingprocess to ensure that each layer of the final printed device wasintegrally attached to each other layer.

In one embodiment, the final printed object may be a medical implant,such as a spinal implant. The spine consists of a column of twenty-fourvertebrae that extend from the skull to the hips. Discs of soft tissueare disposed between adjacent vertebrae. In addition, the spine enclosesand protects the spinal cord, defining a bony channel around the spinalcord, called the spinal canal. There is normally a space between thespinal cord and the borders of the spinal canal so that the spinal cordand the nerves associated therewith are not pinched.

Over time, the ligaments and bone that surround the spinal canal canthicken and harden, resulting in a narrowing of the spinal canal andcompression of the spinal cord or nerve roots. This condition is calledspinal stenosis, which results in pain and numbness in the back andlegs, weakness and/or a loss of balance. These symptoms often increaseafter walking or standing for a period of time.

There are a number of non-surgical treatments for spinal stenosis. Theseinclude non-steroidal anti-inflammatory drugs to reduce the swelling andpain, and corticosteroid injections to reduce swelling and treat acutepain. While some patients may experience relief from symptoms of spinalstenosis with such treatments, many do not, and thus turn to surgicaltreatment. The most common surgical procedure for treating spinalstenosis is decompressive laminectomy, which involves removal of partsof the vertebrae. The goal of the procedure is to relieve pressure onthe spinal cord and nerves by increasing the area of the spinal canal.

Interspinous process decompression (IPD) is a less invasive surgicalprocedure for treating spinal stenosis. With IPD surgery, there is noremoval of bone or soft tissue. Instead, an implant or spacer device ispositioned behind the spinal cord or nerves and between the interspinousprocesses that protrude from the vertebrae in the lower back.

Prior medical implants have limited porosity for encouraging bonegrowth. Known implants may have only surface porosity on an outersurface thereof or discrete openings in defined layers. The presentinvention provides an improvement over prior implant devices by creatingan implant that is porous throughout the entire internal structure. Theimplant may have a lattice-type structure that allows for interconnectedpores extending throughout the entire device. This will advantageouslyimprove the integration of the implant into the body and encourage bonegrowth therein.

SUMMARY

Embodiments of the invention solve the above-mentioned problems byproviding a system and method for printing a customized object, such asa surgical implant, using a printing device having multiple heatedelements that are configured to maintain the printing material at apredetermined temperature during the entire printing process.

The construction of the implant according to an embodiment of theinvention also allows for customizing the implant to have multipledifferent portions with different porosities.

A first embodiment of the invention is directed to a printing device forforming a surgical implant from a first material comprising: a housingforming an enclosed space; a print head comprising a heated nozzle forextruding the first material; a planar heated build plate having a topsurface for receiving the first material thereon; a reflective platecomprising an active heating element. The reflective plate is locatedadjacent the heated nozzle and has a bottom surface configured toreflect heat towards the build plate. The reflective plate, the heatedbuild plate, and the heated nozzle are all configured to maintain thefirst material at a predetermined temperature while forming the surgicalimplant.

Another embodiment of the invention is directed to a method for using aprinting device to create a medical implant, the method comprising:providing a first material for printing the medical implant; providing aprinting device; moving the print head and the reflective platevertically in a Z-plane; and moving the build plate horizontally in aX-plane and in a Y-plane. The printing device comprises: a housingforming an enclosed space; a print head comprising a heated nozzle forextruding the first material; a planar heated build plate having a topsurface for receiving the first material thereon; and a reflective platecomprising an active heating element. The reflective plate is locatedadjacent the heated nozzle and has a bottom surface configured toreflect heat towards the build plate. The reflective plate, the buildplate, and the nozzle are all configured to maintain the first materialat a predetermined temperature while forming the medical device.

Another embodiment of the invention is directed to a system for 3-Dprinting a medical device comprising: a printing material for formingthe medical device; and a printing device. The printing devicecomprises: a housing forming an enclosed space; a print head comprisinga heated nozzle for extruding the printing material; a planar heatedbuild plate having a top surface for receiving the printing materialthereon; a reflective plate comprising an active heating element. Thereflective plate is located adjacent the heated nozzle and has a bottomsurface configured to reflect heat towards the build plate. Thereflective plate, the build plate, and the nozzle are all configured tomaintain the printing material at a predetermined temperature whileforming the medical device.

Yet other embodiments of the invention are directed to one or morenon-transitory computer-readable media storing computer executableinstructions, that, when executed by a processor, perform a method ofthree-dimensionally printing a medical implant, the method comprising:selecting a custom final shape of the implant based at least in part onan anatomy of a particular patient; selecting a first porosity for afirst region and selecting a second porosity for a second region of theimplant; providing a printing material to a nozzle of a printing device;heating the printing material to at least a glass transitiontemperature; and dispensing a plurality of layers of the printingmaterial through the nozzle onto the build plate to form the implant.

Another embodiment of the invention is directed to a method for printinga medical implant comprising: providing a printing material and aprinting device including a nozzle; selecting a final shape, size, andconfiguration of the implant; selecting a first porosity for a firstregion of the implant; selecting a second porosity for a second regionof the implant; controlling a dispense rate of the printing materialfrom the nozzle onto a build plate; monitoring a temperature of at leastone portion of the printing device by at least one temperature sensor;and adjusting the temperature of at least one element of the printerdevice to maintain the implant at a predetermined temperature during theentire printing process.

Another embodiment of the invention is directed to a method for forminga porous surgical device by contiguous deposition comprising: providinga printing material; extruding the printing material through a nozzlehead; moving the nozzle head vertically in a Z-plane; receiving theprinting material on a top surface of a build plate; moving the buildplate horizontally in a X-plane and in a Y-plane; and depositing aplurality of layers of the printing material on the build plate to formthe surgical device. Depositing the plurality of layers of the printingmaterial further comprises: a) depositing a first layer on the buildplate; b) rotating the substantially contiguous pattern by about 36°;and c) depositing a second layer on top of the first layer; andrepeating steps a, b, and c until a predetermined number of layers areformed.

A further embodiment of the invention is directed to a selectivelyporous customizable medical implant made by the process of fusedfilament fabrication (FFF) by a printer comprising: at least a firstregion having a first porosity; at least a second region having a secondporosity, wherein the pores of the first region are larger than thepores of the second region. The first region may have a latticestructure with interconnected pores. The implant may be made of apolymer, such as polyether ether ketone (PEEK). The implant may furtherinclude a coating of hydroxyapatite that extends into the pores.

Another embodiment of the invention is directed to a spinal implantformed by a polymer monofilament printing process, comprising: a topsurface, a bottom surface, a peripheral outer surface, and a centralopening; and a porous section having a plurality of interconnectedpores. The porous section has a first plurality of openings on the topsurface and a second plurality of openings on the bottom surface. Theimplant shape and pore size is selectable for customizing the implant toa particular patient.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used to limit the scope of the claimed subject matter. Other aspectsand advantages of the invention will be apparent from the followingdetailed description of the embodiments and the accompanying drawingfigures.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

Embodiments of the invention are described in detail below withreference to the attached drawing figures, wherein:

FIG. 1A is a perspective view of the exterior of a first embodiment ofthe printing device of the invention;

FIG. 1B is a schematic view of the interior of the first embodiment ofthe printing device;

FIG. 2A is a perspective view of a first embodiment of the build platein an assembled state.

FIG. 2B is an exploded view of the first embodiment of the build plate;

FIG. 3A is a perspective view of a first embodiment of the upperassembly of the invention in an assembled state;

FIG. 3B is an exploded view of the first embodiment of the upperassembly;

FIG. 4 is a cross-sectional view of an embodiment of the print head ofthe invention;

FIG. 5 is a perspective view of the interior of the printing unit of theinvention;

FIG. 6 is a perspective view of a material housing and printing materialof the invention;

FIG. 7 depicts an exemplary hardware platform for certain embodiments ofthe invention;

FIG. 8A is a perspective view of an embodiment of a printed object thatmay be printed by the printing device of the invention;

FIG. 8B is a perspective view of a first layer of an exemplaryembodiment of the printed object;

FIG. 8C is a perspective view of a second layer deposited onto the firstlayer of the embodiment of FIG. 8B;

FIG. 8D is a perspective view of an exemplary embodiment of a medicalimplant that may be printed by printing device of the invention;

FIG. 8E is a cross-sectional view of the exemplary embodiment of themedical implant of FIG. 8D;

FIG. 9 is an exemplary flowchart illustrating a method of using theprinting device of the invention;

FIG. 10 is a perspective view of an exemplary anterior cervicalinterbody cage for anterior cervical interbody fusion (ACIF) surgerythat may be printed by printing device of the invention;

FIG. 11 is a perspective view of an exemplary lumbar spine cage forposterior lumbar interbody fusion (PLIF) surgery that may be printed byprinting device of the invention;

FIG. 12 is a perspective view of an exemplary lumbar spine cage fortransforaminal lumbar interbody fusion (TLIF) surgery that may beprinted by printing device of the invention; and

FIG. 13A-E are exemplary embodiments of additional medical implants thatmay be printed by printing device of the invention.

The drawing figures do not limit the invention to the specificembodiments disclosed and described herein. The drawings are notnecessarily to scale, emphasis instead being placed upon clearlyillustrating the principles of the invention.

DETAILED DESCRIPTION

The following detailed description references the accompanying drawingsthat illustrate specific embodiments in which the invention can bepracticed. The embodiments are intended to describe aspects of theinvention in sufficient detail to enable those skilled in the art topractice the invention. Other embodiments can be utilized and changescan be made without departing from the scope of the invention. Thefollowing detailed description is, therefore, not to be taken in alimiting sense. The scope of the invention is defined only by theappended claims, along with the full scope of equivalents to which suchclaims are entitled.

In this description, references to “one embodiment,” “an embodiment,” or“embodiments” mean that the feature or features being referred to areincluded in at least one embodiment of the technology. Separatereferences to “one embodiment,” “an embodiment,” or “embodiments” inthis description do not necessarily refer to the same embodiment and arealso not mutually exclusive unless so stated and/or except as will bereadily apparent to those skilled in the art from the description. Forexample, a feature, structure, act, etc. described in one embodiment mayalso be included in other embodiments but is not necessarily included.Thus, the technology can include a variety of combinations and/orintegrations of the embodiments described herein.

FIGS. 1A-1B illustrate one embodiment of printing device 10. Printingdevice 10 may be a three-dimensional printer or an additivemanufacturing printer, which is configured to form printed objects 800from a printing material. In some embodiments, printing device 10 may beused to manufacture objects 800 using any known or yet to be discoveredmethod of additive manufacturing, including but not limited to inkjet,material extrusion, light polymerized, powder bed, laminated, powderfed, or wire methods of additive manufacturing. In some embodiments,printing device 10 is a fused filament fabrication (FFF) printer. Insome embodiments, printing device 10 is supplied with a printingmaterial, such as PAEK, PEEK, polyetherketoneketone (PEKK), and/or otherhigh-performance plastics, and combinations thereof. Additional printingmaterials include acrylonitrile butadiene styrene (ABS), polylactic acid(PLA), poly-ethylene terephthalate (PET), poly-ethylene trimethyleneterephthalate (PETT), nylon filament, polyvinyl alcohol (PVA), sandstonefilament, and combinations thereof. Printing material may be supplied tothe printing device 10 in multiple forms. In one embodiment, printingmaterial is supplied in a filament form.

FIG. 1A shows the exterior of printing device 10 comprising a housingunit 12. Housing unit 12 may comprise a frame 14 for supporting andenclosing the components of printing device 10. In some embodiments,frame 14 may be generally be designed as a rectangular housing unit,however, it will be appreciated that frame 14 may be designed in anygeometric shape or design, such as cylindrical or square.

Furthermore, the dimensions of frame 14 may likewise vary depending onthe embodiment, and for example, may be configured based on thedimensions of the final printed object. For example, in someembodiments, frame 14 may comprise the following dimensions: a length ofabout 25 inches to about 45 inches; a width of about 18 inches to 38inches; and a height of about 33 inches to 53 inches. Frame 14 may beconstructed from any suitable material, including but not limited tometallic alloys such as aluminum, magnesium, titanium, stainless steel,or other known structural frame materials.

In some embodiments, frame 14 may support at least one panel 16 thereon.In some embodiments, multiple panels 16 may be provided to form anenclosure for protecting printing object 800. For example, panels 16 mayform a cube-like enclosure, as seen in FIG. 5. Panels 16 may provide apartially or fully closed-frame design to aid in maintaining a desiredtemperature inside housing unit 12. The partially or fully closed-framedesign may also prevent a user from contacting the inside of theprinting device 10 during operation.

Panels 16 may be constructed from any suitable material, including butnot limited to metallic alloys, such as aluminum, magnesium, titanium,stainless steel, or other known materials. In some embodiments, panels16 may be composed of at least one material having a thermallyinsulating property to aid in maintaining the desired temperature insidehousing unit 12 during operation. In some embodiments, at least oneinterior surface of panel 16 may include a thermally insulating material18. In some embodiments, thermally insulating material 18 may be appliedas a lining or additional layer, may be manufactured into panels 16, ormay be applied as a coating on a surface of panels 16. In someembodiments, panels 16 may be manufactured from a material that hasinherent thermally insulating properties or such material may be addedduring the manufacturing process.

In some embodiments, frame 14 may further comprise at least one meansfor accessing the interior of housing unit 12, such as one or more doors20 or a hatch. In some embodiments, doors 20 are configured with handlesand rotate on hinges. In some embodiments, one or both doors 20 mayfurther comprise a viewing portal 22 or window for observing theinterior of housing unit 12 during operation of printing device 10.Viewing portal 22 may be constructed from any suitable transparent ortranslucent material and, for example, may be laminated safety glass. Insome embodiments, viewing portal 22 may be located on one of panels 16supported on frame 14. In some embodiments, there may be a plurality ofviewing portals 22 located on door 20, panels 16, or any combinationthereof. Printing device 10 may also have a safety shut-off switch 24,which may be located on a front panel. Printing device 10 may also havea key lock 26 for locking the doors 20 while the printing device 10 isin operation. In some embodiments, the printing device 10 automaticallylocks the door 20 to prevent a user from opening the chamber duringprinting.

As further illustrated in FIG. 1A, printing device 10 may comprise acontrol system 50, which is communicatively coupled to printing device10. Control system 50 may comprise a processor, which as described ingreater detail herein, may be configured to receive custom designparameters from a user for controlling printing device 10 before and/orduring operation. Control system 50 may further comprise a display 52.Display 52 may provide an interface for inputting instructions, such asa touch-screen interface. Display 52 may also provide any information toa user about printing device 10 before, during, and after operation. Forexample, display may provide information that may be required forpre-operation, post-operation, diagnostic testing, and/ortroubleshooting. An additional computer 702 may be connected to printingdevice 10. Computer 702 may allow a user to input additionalinstructions and is configured to interact with control system 50.

FIG. 1B illustrates a schematic view of the interior of housing unit 12,illustrating additional components of printing device 10. It is notedthat panels 16 are not shown in this view in order to better see theother internal components. In some embodiments, printing device 10 maycomprise a build plate 100, a print head 200, and a reflector unit 300.As can be seen in FIG. 1B, frame 14 supports an upper assembly 201 and alower assembly 260. Lower assembly 260 includes a support structure 262for receiving build plate 100 thereon. Upper assembly 201 includes asupport structure 278 for receiving print head 200 and reflector unit300 thereon. In some embodiments, build plate 100 may be positionedbelow print head 200 and reflector unit 300. Build plate 100 isconfigured to receive the printed material 400 thereon to form theobject 800.

FIGS. 2A-2B illustrate an embodiment of build plate 100. FIG. 2Aillustrates a perspective view of build plate 100 in an assembled stateand FIG. 2B is an exploded view. In one embodiment, build plate 100 maybe designed in a generally rectangular shape and configuration. However,in other embodiments build plate 100 may be designed in any geometricshape and may be for example circular, triangular, rectangular,pentagonal, or any other polygonal geometric shape or design.Furthermore, it will be appreciated that the size and shape of buildplate 100 may also vary depending on the embodiment and the desired use.However, build plate 100 may generally be designed such that it islarger than the desired dimensions of the object 800 to be printed.Thus, the entirety of the printed object 800 may be received within theinterior perimeter of build plate 100.

With reference to FIG. 2B, in some embodiments, build plate 100 maycomprise a plurality of layers. In some embodiments, build plate 100comprises a flat and planar design. In some embodiments each of theplurality of layers of build plate 100 may comprise a generally flat andplanar shape and design. Alternatively, in some embodiments each of theplurality of layers may comprise other shapes and designs, and forexample, may comprise curved, concave, or convex designs. In oneembodiment, as seen in FIG. 2B, build plate 100 may comprise a bottomframe layer 102, at least one insulating layer 104, at least one heatinglayer 106, at least one intermediate layer 108, a top frame layer 109and a top build layer 110. It will be appreciated that in someembodiments, build plate 100 may comprise greater or fewer layers.

In one embodiment, bottom frame layer 102 may be constructed fromaluminum. In alternative embodiments, bottom frame layer 102 may beconstructed from other materials, such as stainless steel, titanium, orother suitable materials and combinations thereof. In some embodiments,upper surface of bottom frame layer 102 may comprise a recess 112 orformed indention, configured such that at least one other layer of buildplate 100 may be placed on and rest in recess 112. Bottom frame layer102 may include one or more openings 105 for receiving fasteners thereinfor anchoring the layers of the build plate together. Specifically, theopenings 105 may receive fasteners for connecting bottom frame layer 102to corresponding openings 113 located on the underside of top framelayer 109. Alternatively, bottom frame layer 102 and top frame layer 109may be connected together by any known means, such as mechanicalfasteners or adhesives. Bottom frame layer 102 may further include oneor more openings 103 for receiving connectors 130 therein for connectingthe build plate 100 to lower assembly 260, as discussed further below.

In some embodiments, build plate 100 may comprise one or more insulatinglayers 104. Insulating layer 104 can act as a heat break in build plate100, limiting, reducing, or eliminating the migration of heat generatedby build plate 100 to undesirable locations. In one embodiment, buildplate 100 includes insulating layer 104 positioned above and adjacent tobottom frame layer 102. In one embodiment, insulating layer 104 may beplanar and generally be configured in the same shape as recess 112 suchthat it is received entirely within recess 112. In one embodiment,insulating layer 104 has a thickness of about 0.2 inches to about 0.3inches. In some embodiments, insulating layer 104 may have a thicknessin a range of from about 0.1 inch to about 0.75 inches. It will beappreciated that in some embodiments, insulating layer 104 can beconstructed from a single material, alloy, or polymer. In alternativeembodiments, insulating layer 104 can be constructed from a mixture ofmultiple materials, alloys, or polymers. Insulating layer 104 can beconstructed from a variety of different materials, alloys, or polymers,each having different thermally insulating properties. For example, inone embodiment, insulating layer 104 can be at least partiallyconstructed from mica. In one embodiment, insulating layer 104 can be atleast partially constructed from ceramic. In one embodiment, insulatinglayer 104 can be at least partially constructed from PEEK, PAEK, orPEKK.

Alternatively, in some embodiments, insulating layer 104 can comprise aplurality of distinct units positioned in recess 112 in a spaced manner.The plurality of units may be designed as any geometric shape and may befor example, round, triangular, rectangular, pentagonal, or any otherpolygonal shape. In some embodiments, the plurality of units are roundand circular in shape. The plurality of units may have any desiredthickness, such as about 0.25 inch. Alternatively, in some embodimentsthe thickness of the plurality of units may be 0.1-0.75 inches thick.The number of units may vary, depending on the embodiment, and mayconsist of any number of desired units. In some embodiments, insulatinglayer 104 may comprise five thermally insulating units.

In some embodiments, build plate 100 may further comprise at least oneheating layer 106. In one embodiment, heating layer 106 may bepositioned above and adjacent to insulating layer 104 and, in someembodiments, may rest against the top surface of insulating layer 104.Heating layer 106 can comprise a selectively operable and/orprogrammable heating element 114 for generating heat and for maintaininga predetermined temperature of the top build layer 110 of build plate100 during operation. In some embodiments, heating layer 106 can be asolid layer of material such as silicone, aluminum, titanium, platinum,or other metal alloys with conductive properties that is capable ofgenerating heat. In some embodiments, heating layer 106 can be coupledto wiring, cables, coils, or other conductive circuitry 116 capable oftransferring an electric current to the heating layer 106. Conductivecircuitry 116 can transfer electricity from an external source, such asa battery or standard electrical outlet, to heating layer 106 forgenerating heat. In some embodiments, heating element 114 and/orconductive circuitry 116 can be communicatively coupled to controlsystem 50. Control system 50 can be programmed and/or configured toreceive instructions from a user to increase and/or decrease the heatgenerated by heating element 114 as desired during operation.

In some embodiments, build plate 100 may further comprise at least oneintermediate layer 108. In some embodiments, intermediate layer 108 canbe positioned above and adjacent to heating layer 106. In someembodiments, intermediate layer 108 can be placed above and rest on thetop surface of heating layer 106. Intermediate layer 108 can be designedin any geometric design or shape, such as circular, triangular,rectangular, pentagonal, or any other polygonal shape. In someembodiments, intermediate layer 108 may generally comprise the sameshape as build plate 100. The dimensions of intermediate layer 108 canfurther vary depending on the embodiment. In some embodiments,intermediate layer 108 will have dimensions such that it can be placedwithin recess 112, along with insulating layer 104 and heating layer106.

In some embodiments, intermediate layer 108 can act as a diffuser,distributing the heat generated by heating layer 106 in a uniform andeven manner. In some embodiments, intermediate layer 108 can aid inpreventing, reducing, or eliminating any focused pockets of heat, or hotspots. Intermediate layer 108 acts to dissipate the hot spots across theentirety of its surface. The dissipation of hot spots can aid in forminga uniform distribution of heat, which creates a more optimum environmenton top surface of build plate 100 for printing an object 800. In oneembodiment, intermediate layer 108 is constructed from stainless steel,however, it will be appreciated that intermediate layer 108 can beconstructed from any suitable material having heat dissipationproperties.

In some embodiments, build plate 100 may further comprise a top framelayer 109. Top frame layer 109 is positioned directly above and adjacentto intermediate layer 108. Top frame layer 109 may be constructed fromaluminum, titanium, stainless steel, or any other suitable material, orcombinations thereof. In some embodiments, top frame layer 109cooperates with bottom frame layer 102 to enclose insulating layer 104,heating layer 106, and intermediate layer 108 therebetween. Top framelayer 109 and bottom frame layer 102 may have similar dimensions suchthat they fit together. Top frame layer 109 may further include one ormore openings 111, which may align with one or more openings 103 inbottom frame layer 102 for receiving connectors 130 therein. In someembodiments, openings 111 and openings 103 are located at the fourcorners of top frame layer 109 and bottom frame layer 102, respectively.Connectors 130 may anchor the build plate 100 to the lower assembly 260,as discussed further below. Alternatively or additionally, connectors130 and openings 111 may further be used for fine bed leveling top buildlayer 109.

In some embodiments, an upper surface of top frame layer 109 maycomprise a recess 122 for receiving a top build layer 110 therein. Thus,top frame layer 109 may have a larger length and width than top buildlayer 110. In some embodiments, top build layer 110 may have a thicknessgreater than the depth of recess 122, such that an upper surface of topbuild layer 110 protrudes therefrom. In some embodiments, top buildlayer 110 and top frame layer 109 has upper surfaces that are flush withone another to form the upper surface of the build plate 100. In someembodiments, recess 122 includes a plurality of holes 119 for receivingfasteners 120 therein.

In some embodiments, top build layer 110 provides a surface forreceiving the printed material thereon to form printed object 800. Topbuild layer 110 may be designed as any geometric shape or design,including but not limited to circular, triangular, rectangular,pentagonal, or any other polygonal shape. As shown in FIG. 2B, top buildlayer 110 may be substantially rectangular. For example, in someembodiments, top build layer 110 can comprise a length of about 1.5inches to about 4.5 inches and further comprise a width of about 1.5inches to about 4.5 inches. In some embodiments, top build layer 110includes a plurality of holes 118 that cooperate with holes 119 in topframe layer 109 for receiving fasteners 120 therein. In one embodiment,fasteners 120 may be used to secure top build layer 110 to top framelayer 109. Securing top build layer 110 to top frame layer 109 aids inpreventing the top build layer 110 from warping or curving during use.Maintaining a planar structure of the top build layer 110 duringoperation ensures reliability in the printed object 800 having a flatbase. In alternative embodiments, top build layer 110 may be secured totop frame layer 109 through any known fastening method, including butnot limited to adhesives or other mechanical fasteners such as forexample nails, bolts, or clamps.

In some embodiments, top build layer 110 can also act as a diffuser,distributing the heat generated by heating layer 106 in a uniform andeven manner. In some embodiments, top build layer 110 can aid inpreventing, reducing, or eliminating any focused pockets of heat, or hotspots. Top build layer 110 acts to dissipate the hot spots across theentirety of its surface. The dissipation of hot spots can aid in forminga uniform distribution of heat, which creates a more optimum environmenton top surface of build plate 100 for printing an object 800. In oneembodiment, top build layer 110 is constructed from stainless steel,however, it will be appreciated that top build layer 110 can beconstructed from any suitable material having heat dissipationproperties.

In some embodiments, top build layer 110 may be constructed at leastpartially from polyetherimide (PEI), PEEK, PAEK, PEKK, Ultem™, or otherthermoplastic polymers or any combination thereof. In some embodiments,top build layer 110 may be partially or fully constructed of glass,aluminum, stainless steel, or other metallic alloys, or combinationsthereof. In some embodiments, top build layer 110 may have a thicknessof about 0.25 inches. In some embodiments, the thickness of top buildlayer 110 may be from about 0.1 inch to about 0.75 inch.

As discussed above, in some embodiments top build layer 110 may comprisea plurality of holes 118 or void spaces in the top surface thereof. Thenumber and placement of holes 118 may vary, depending on the embodiment.In some embodiments, the number and placement of holes 118 maycorrespond to the number and placement of holes 119 in top frame layer109. Holes 118 may be machined or manufactured into top build layer 110during construction, or alternatively, may be placed in top build layer110 after construction. In some embodiments, holes 118 may beselectively positioned in rows and/or columns of a predeterminedquantity. In some embodiments, holes 118 may be placed randomly, withouta predetermined selection of placement. In some embodiments, holes 118may be througholes extending completely through top build layer 110,thereby creating continuous openings into top build layer 110.Alternatively, in some embodiments one or more holes 118 may be definedpartially into top build layer 110 and stop short of creating acontinuous opening entirely through top build layer 110. In someembodiments, top build layer 110 may comprise a combination ofthrougholes 118 and partial holes 118.

In some embodiments, as heat generated by heating layer 106 begins tomove up in the z-plane of the build plate 100 and reaches top buildlayer 110, holes 118 may aid in distributing the heat across the entiresurface of top build layer 110. In some embodiments, holes 118 may alsoaid in dissipating the heat as it reaches top build layer 110. Asdescribed in greater detail below, printing device 10 may furthercomprise additional heat sources, and in some embodiments the additionalheat sources may be located axially above top build layer. In additionto distributing and dissipating heat directed from the lower heatinglayer 106, top build layer 110 may further distribute and dissipate heatfrom the above additional heat sources, in a similar manner. Thedistribution or dissipation of heat can help to prevent, reduce, oreliminate the build-up of hot spots or heat sinks on top build layer110. The reduction or elimination of hot spots and heat sinks can bebeneficial during operation, as this may cause warping or distortion ofthe top build layer 110 and/or of the final printed object 800. In someembodiments, top build layer 110 may be comprised of a thermal expansionmaterial, that expands as the temperature within housing unit 12increases. In such an embodiment, holes 118 can aid in providing spacingor clearance for the material to expand, thus preventing and/or reducingwarping of top build layer 110.

In some embodiments, at least some of the void spaces created by holes118 may be filled with a compatible element. In some embodiments, one ormore holes 118 may receive mechanical fasteners 120 such as screws,nails, glue or epoxy, or other suitable fasteners therein. In someembodiments, fasteners 120 may be constructed from aluminum, titanium,stainless steel, or other metallic alloys. In some embodiments,fasteners 120 may be constructed from a thermoplastic polymer. In someembodiments, fasteners 120 may be constructed from any known or yet tobe discovered material that is capable of maintaining its form and shapeup to the highest temperature range that printing device 10 is capableof achieving. Fasteners 120 may aid in increasing the heat distributionor dissipation properties of top build layer 110. For example, fasteners120 may aid in distributing or dissipating heat generated from heatinglayer 106 across the surface of top build layer 110.

In some embodiments, fasteners 120 may be used to mechanically coupletop build layer 110 to at least one of the plurality of layers of buildplate 100, such as top frame layer 109. Alternatively, in someembodiments, each of the plurality of layers of build plate 100 maysecured together through the use of mechanical fasteners, such asscrews, bolts, or epoxy.

For example, as illustrated in FIG. 2B, in some embodiments bottom framelayer 102 may form the bottom of build plate 100. Insulating layer 104may be positioned within recess 112. Heating layer 106 may then beplaced within recess 112 adjacent to and on top of insulating layer 104.Intermediate layer 108 may then be positioned within recess 112 adjacentto and on top of heating layer 106. Top frame layer 109 may then beplaced on top of bottom frame layer 102, acting as an enclosure forinsulating layer 104, heating layer 106, and intermediate layer 108. Topframe layer 109 and bottom frame layer 102 can then be coupled orsecured together using mechanical fasteners, adhesives, or otherfastening methods. Top build layer 110 may be positioned within recess122 of top frame layer 109 and anchored therein, as discussed above.

In some embodiments, build plate 100 may further include at least oneoptional or additional cooling device (not shown) to aid in regulatingthe temperature of build plate 100. In some embodiments, a coolingdevice may be located internally within build plate 100. In someembodiments, printing device 10 may include an additional cooling devicelocated externally from build plate 100. Cooling device may beconfigured as any known system or device for cooling hardware or partsand may be configured as a fan, a baffle, a water-cooling device, or anyother known cooling devices or systems. In some embodiments, there maybe a plurality of cooling devices for cooling heated build plate 100.

In some embodiments, build plate 100 can be positioned below print head200 in the z-plane and provide a printing surface for receiving printingmaterial thereon. In some embodiments, printing material can be printeddirectly onto top build layer 110. In some embodiments, heat generatedby heating layer 106 can transfer up through build plate 100 and reachtop build layer 110, where the heat may then be distributed across thetop surface of top build layer 110. This distribution of heat canreduce, prevent, or eliminate the presence of heat sinks or hot spots,which can cause warping of printed objects 800 and/or top build layer110.

In some embodiments, a heated build plate 100 can aid in improving thequality of the printed object 800. For many printing filaments andmaterials, there can be a tendency for the material to crystallize if itcools too quickly after being dispensed, Therefore, it is advantageousto maintain the temperature of the printing material while it is on theprinting surface, such as top build layer 110. In some embodiments, heatgenerated from heating layer 106 can transfer up through the z-planeuntil reaching top build layer 110. Once reaching top build layer 110,the heat can dissipate or otherwise be distributed throughout top buildlayer 110. The heat generated from heating layer 106 and dissipated intop build layer 110 can create a heating effect to the printed object,thereby preventing or reducing crystallization of the printed object800.

In some embodiments, build plate 100 may be configured to operationallyand selectively move in the z-plane. Lower assembly 260 includes asupport structure 262 for receiving build plate 100 thereon. In someembodiments, build plate 100 may be secured to support structure 262 viaconnectors 130, whereby connectors 130 anchor build plate 100 to supportstructure 262. Alternatively or additionally, in some embodiments buildplate 100 may be configured to move in the x-y plane. In someembodiments, as illustrated in FIG. 1B, build plate 100 may be attachedvia support structure 262 to a motorized lower drive train 124 ormechanized platform having a motor 126, that can be selectively andcontrollably configured to move in the z-plane and/or the x-y plane. Insome embodiments, motorized lower drive train 124 can comprise a firstlower sub-assembly 264 and a second lower sub-assembly 266. In someembodiments, first lower sub-assembly 264 can be configured to movebuild plate 100 in the x-plane. In some embodiments, second lowersub-assembly 266 can be configured to move build plate 100 in they-plane. Alternatively, in some embodiments, first lower sub-assembly264 can be configured to move build plate 100 in the y-plane. In someembodiments, second lower sub-assembly 266 can be configured to movebuild plate 100 in the x-plane. In some embodiments, lower drive train124 can be communicatively coupled to control system 50. Control system50 can be programmed and/or configured to command lower drive train 124to move up and/or down in the z-plane and/or to move laterally in thex-y plane. In some embodiments, control system 50 can respond to manualcontrols for moving build plate 100. In some embodiments, control system50 can be programmed with a machine learning algorithm and instructionsto move build plate 100 in response to certain predetermined parameterssuch as, for example, temperature of the interior of housing unit 12,temperature of the printed object 800, and/or distance between buildplate 100 and print head 200. In alternative embodiments, lower drivetrain 124 may be manually operated by a non-motorized means. Forexample, lower drive train 124 could be manually operated by amechanical lift. It will be appreciated that there are numerous methodsand systems that could be implemented for moving build plate 100 in thez-plane and/or in the x-y plane, and any suitable method or system couldbe implemented in the present invention.

FIGS. 3A-3B illustrate an embodiment of a portion of upper assembly 201.FIG. 3A illustrates a perspective view of upper assembly 201 in anassembled state and FIG. 3B shows an exploded view thereof.

In some embodiments, upper assembly 201 may be used for heating anddispensing a printing material, such as printing filament 400. As can beseen in FIG. 1B, upper assembly 201 includes a support structure 278 forreceiving print head 200 and reflector unit 300 thereon. Upper assembly201 includes coupling plate 272, bracket 274, and vertical support 270.Upper assembly 201 also includes a motor 276 operatively connected to anupper drive train 280. In some embodiments, coupling plate 272 isanchored to support structure 278 and bracket 274 is anchored tocoupling plate 272. Bracket 274 receives vertical support 270 thereinand is anchored thereto. In some embodiments, print head 200 andreflector unit 300 are secured to vertical support 270.

In some embodiments, vertical support 270 may be coupled to an upperdrive train 280, for selectively moving vertical support 270 and thecomponents secured to vertical support 270. Upper drive train 280 may beconfigured to selectively move in the z-plane. In some embodiments,upper drive train 280 can be communicatively coupled to control system50. Control system 50 can be programmed and/or configured to commandupper drive train 280 vertically in the z-plane. In some embodiments,upper drive train 280 may additionally or alternatively be configured toselectively move in the x-y plane. In some embodiments, control system50 can respond to manual controls for moving print head 200 andreflector unit 300. In some embodiments, control system 50 can beprogrammed with a machine learning algorithm and instructions to moveprint head 200 in response to certain predetermined parameters, such asfor example the temperature of the interior of housing unit 12, thetemperature of the printed object 800, or the distance between buildplate 100 and print head 200. In alternative embodiments, upper drivetrain 280 may be a manually operated by a non-motorized means. Forexample, upper drive train 280 could be manually operated by amechanical lift. It will be appreciated that there are numerous methodsand systems that could be implemented for moving print head 200 andreflector unit 300 in the z-plane and/or the x-y plane, and any suitablemethod or system could be implemented in the present invention.

FIG. 4 illustrates a cross-sectional view of print head 200. In someembodiments, print head 200 may consist of various components and partsfor heating and dispensing printing material, such as printing filament400. In some embodiments, print head 200 may comprise a cooler 204, aheater 206, at least one bridge 208, and a nozzle 210. Print head 200may further comprise a feed tube 212 for feeding printing material 400into and through print head 200 prior to dispensing printing material400 onto build plate 100. Feed tube 212 may be constructed from a metal,such as aluminum, titanium, or any other suitable material. In someembodiments, feed tube 212 may extend generally axially. Feed tube 212may comprise an inlet 214 for receiving a forwardly driven printingfilament 400 of a solid disposition material. Feed tube 212 may furthercomprise an outlet 216, positioned downstream from inlet 214. An hollowinternal passage 218 may connect inlet 214 to outlet 216. Internalpassage 218 may comprise an upstream portion 220 and a downstreamportion 222. In some embodiments, feed tube 212 may have an innersurface coated with an adhesion-reducing substance to prevent theprinting material 400 from sticking thereto. For example, inner surfaceof feed tube 212 may be coated with electroless nickel, an electrolessnickel-boron composite, tungsten disulfide, molybdenum disulfide, boronnitride, diamond-like carbon, or any other suitable material, orcombinations thereof.

In some embodiments, heater 206 may be thermally coupled with downstreamportion 222. Heater 206 may be used for heating the printing filament400 as the printing filament 400 passes through feed tube 212 andreaches downstream portion 222. Heater 206 may comprise a heatingelement 224, which can be selectively controlled to heat printingfilament 400. In some embodiments, heating element 224 may be athermally conductive material comprising a heater, such as a glow wireor conductive circuitry. In some embodiments, heating element 224 may beany known electrical or chemical heating element. In some embodiments,heater 206 may be communicatively coupled to control system 50, forselectively controlling the parameters of heater 206. For example,control system 50 may control when heater 206 is activated, the durationof the activation, and/or the amount of generated heat such thatprinting material 400 may be maintained at the desired temperature. Insome embodiments, heater 206 may be manually controlled and adjusted byinputs entered into control system 50. In some embodiments, heater 206may be automatically controlled based on predetermined parameters andadjusted by control system 50 for automatically regulating temperatureof printing material 400 during operation.

In some embodiments, heater 206 may be heated to a temperature that iscapable of melting printing filament 400 as printing material 400 istransported through downstream portion 222. For example, in someembodiments printing material 400 may be a PEEK filament. Heater 206 mayheat printing material 400 to at least 430° C. In some embodiments,heater 206 can be configured to heat printing material 400 from about130° C. to about 500° C. Printing material 400 may be selected from anyknown material or filament for printing or additive manufacturing, andheater 206 can be configured to heat the printing material 400 to atleast a melting temperature.

In some embodiments, cooler 204 may be thermally coupled with upstreamportion 220 and can be used for regulating the temperature of printingfilament 400 as it passes through feed tube 212. In some embodiments,cooler 204 may be spaced generally axially upstream from heater 206 witha defined gap 226 or space separating cooler 204 from heater 206. Gap226 may be filled with at least one bridge 208, providing a rigidmechanical connection between heater 206 and cooler 204. In someembodiments, cooler 204 may comprise a thermoelectric cooler or a heatsink comprising heat-conductive material. In some embodiments, cooler204 may comprise a strain-hardened stainless steel surgical tubing,which may have a thermal conductivity of less than about 15 W/mK, atensile strength of greater than about 100 MPA, and a surface roughnessof less than about 0.5 μm. In some embodiments, cooler 204 may comprisean internal heat transfer passage (not shown) configured to receive acooling fluid. In some embodiments, a heat transfer passage may beconfigured to receive air for cooling. In some embodiments, upstreamportion 220 may further be coupled with at least one secondary cooler228 for directly cooling printing material 400.

In some embodiments, print head 200 may be configured to comprise a hotzone 240. Hot zone 240 may generally be a defined space, void, or heatbreak zone positioned approximately in the area between heater 206 andcooler 204 and secondary cooler 228. In some embodiments, hot zone 240can provide a clean line of separation, separating the heat generatedfrom heater 206 from the cooler temperatures defined by the cooler 204and secondary cooler 228. For example, as printing material 400 passesthrough feed tube 212, it is advantageous for the printing material 400to remain in a solid state until reaching the break zone of hot zone240. As printing material 400 travels down through downstream portion222 and reaches hot zone 240, printing material 400 can begin to beheated by heater 206. The heat generated by heater 206 begins to heatand melt printing material 400 only after printing material 400 passesthrough hot zone 240, transitioning printing material 400 from a solidto a molten liquid state. In some embodiments, the heater 206 comprisesa copper alloy, which may have a conductivity of greater than about 300w/mK, and a tensile strength of greater than about 500 MPA, which isespecially resistant to creep at high temperatures. The heat flowsefficiently inward through the heater 206 to melt the filament quickly.Hot zone 240 maintains printing material 400 in a solid state untilreaching downstream portion 222 surrounded by heater 206. The clean lineof separation defined by hot zone 240 further prevents heat creep infeed tube 212. For example, in FFF printing systems, it is problematicto heat printing material 400 prior to dispensing. Heating printingmaterial 400 prior to dispensing can cause the printing material tocrystalize, which can lead to imperfections in the final printed object.In some embodiments, hot zone 240 can have a dimension of about 0.5 mmto about 1.5 mm, such that there is minimal space between the solid andthe melted material.

Print head 200 may further comprise a nozzle 210, which may be attachedto heater 206 and coupled to outlet 216 of feed tube 212. Nozzle 210 maybe the lowest positioned part of print head 200 and may further be thefinal part that printing filament 400 passes through prior todispensing. Nozzle 210 may be smooth bored or threaded, depending on theembodiment. In some embodiments, an inner surface of nozzle 210 may becoated with an adhesion-reducing material. In some embodiment, theadhesion-reducing material may be electroless nickel, an electrolessnickel-boron composite, tungsten disulfide, molybdenum disulfide, boronnitride, diamond-like carbon, or any other suitable material, orcombination thereof. The diameter of nozzle 210 may vary, depending onthe embodiment, and may be designed to generally match of dimensions ofprinting material 400. In some embodiments the diameter of nozzle 210may be selected from a range of about 0.2 mm to about 0.5 mm.Furthermore, it will be appreciated that in some embodiments, nozzle 210may be removable and replaceable. In some embodiments, a plurality ofnozzles 210 each having a different diameter or size may be providedwhereby a user may select a desired size. For example, in someembodiments printing material 400 may comprise a filament having adiameter of about 1.75 mm, which requires a nozzle 210 having a diameterof about 0.2 mm to about 0.5 mm. A nozzle 210 having a diameter of 3 mmcan be selected from a plurality of nozzles 210 and attached to printhead 200 for dispensing a particular printing material 400.

In some embodiments, print head 200 may further comprise one or moresensors 242 for measuring the temperature of printing material 400, feedtube 212, heater 206, cooler 204, and/or any other portion of print head200. Sensors 242 may be located internally at various locations withinprint head 200 or alternatively, may be externally located. In someembodiments, sensors may be communicatively coupled to control system 50and the measurement therefrom may be provided to display 52.

In some embodiments, printing device 10 may comprise a reflector unit300 that cooperates with print head 200. In some embodiments, reflectorunit 300 may be located adjacent to and/or partially surrounding printhead 200. In some embodiments, reflector unit 300 comprises a reflectiveplate 302 having a bottom surface 314 configured to reflect heat towardsbuild plate 100 and/or the printed object 800. In some embodiments,reflective plate 302 may be constructed from a material having heatreflecting properties. For example, reflective plate 302 may beconstructed from stainless steel, aluminum, titanium, or other materialshaving heat reflecting properties. In some embodiments, reflective plate302 is a thick film stainless steel plate.

Reflective plate 302 may generally comprise any geometric shape anddepending on the embodiment may be circular, triangular, rectangular,pentagonal, or any other geometric shape. The dimensions of reflectiveplate 302 may further vary, depending on the embodiment. In someembodiments, reflective plate 302 may have a dimension that is largerthan the dimensions of the object 800 being printed. In someembodiments, reflective plate 302 may have a maximum dimension such thatwhen reflector unit 300 is moved in the x-y plane, reflective plate 302will not come into contact with frame 14, panels 16, or thermallyinsulating material 18.

For example, in some embodiments, printing device 10 may be used forprinting three-dimensional objects 800, such as medical implants. Suchimplants may have a dimension of about three inches in width and/orlength. In some embodiments, reflective plate 302 may have a dimensionthat is at least larger than the dimension of the three-dimensionallyprinted object 800. In some embodiments, reflective plate 302 may have adimension of about 140 mm². In some embodiments, reflective plate 302may have larger or smaller dimensions, such as about 25 mm² to about 300mm².

In some embodiments, reflector unit 300 may be configured to be anactive heater. In some embodiments, when in an off or non-energizedstate, reflector unit 300 may be configured to be a passive heatreflector. In some embodiments, bottom surface 314 of reflective plate302 reflects heat, which may be generated by build plate 100 or othersources of heat, towards top build layer 110 and/or the printed object800 during operation. In some embodiments, reflector unit 300 canreflect heat generated from heating layer 106 and thus heat the printedobject 800 from multiple directions. For example, in some embodimentsthe printed object 800 can be heated from below by heating layer 106 andfrom above by reflector unit 300. The reflection of heat by reflectorunit 300 can aid in maintaining a desired temperature of the printedobject 800, preventing unwanted crystallization or warping. A controlledheat environment aids in forming a more uniform and structurally soundprinted object 800.

In some embodiments, reflector unit 300 may further comprise an activeheater 303 configured to be selectively controlled. In some embodiments,active heater 303 may be configured to generate heat, which may bedirected towards the top surface of build plate 100 and/or the printedobject 800. In some embodiments, active heater 303 may be positioned ontop surface of reflective plate 302. In some embodiments, active heater303 can be constructed from a conductive material, such that when anelectric current is applied thereto, the conductive material generatesheat. In some embodiments, reflective plate 302 can comprise a plate ofat least partially composed of a thermally insulating material, havingan active heater 303, such as a glow wire, conductive conduit, or otherconductive material positioned on a top surface thereof. The activeheater 303 may generate heat when an electric current is appliedthereto. Active heater 303 can be coupled to an energy source, such as abattery or electrical outlet, for supplying an electrical current toactive heater 303. In some embodiments, an energy source may beincorporated into printing device 10. In some embodiments, an energysource may be external to the printing device 10.

In some embodiments, reflector unit 300 may further comprise a reflectorhousing 306 and an insulator 304. In some embodiments, insulator 304 maybe placed on a spacer, providing a gap between reflective plate 302 andinsulator 304. Reflective plate 302 and insulator 304 may be attachedand secured within reflector housing 306. In some embodiments, reflectorhousing 306 may be configured to have the same general shape and designas reflective plate 302. In some embodiments, insulator 304 may beconfigured to have the same general shape and design as reflective plate302. In some embodiments, insulator 304 can have dimensions such that itmay be placed and secured between reflector housing 306 and reflectiveplate 302. Reflector housing 306 may include side walls 316 forming arecess 318. Insulator 304 and reflective plate 302 may be receivedwithin recess 318 of reflector housing 306, as seen in FIGS. 3A and 3B.In order to anchor the reflector unit 300 together, in some embodiments,plate 302 includes holes 322, insulator 304 includes holes 324, andreflector housing 306 includes holes 326 for receiving connectorstherethrough.

In some embodiments, reflector unit 300 can be configured to at leastpartially surround print head 200. As illustrated in FIGS. 3A and 3B, inone embodiment, a central opening 308 may be defined in reflective plate302, a central opening 310 may be defined in insulator 304, and acentral opening 312 may be defined in reflector housing 306. Openings308, 310, and 312 may be aligned such that they create one continuousopening when reflective plate 302, insulator 304, and reflector housing306 are assembled. In some embodiments, openings 308, 310, and 312 maybe configured to correspond to the shape of the distal end of print head200. In some embodiments, a distal portion of print head 200 may passthrough openings 308, 310, and 312 such that reflector unit 300 at leastpartially surrounds print head 200. As illustrated in FIG. 3A, in someembodiments, a distal end of print head 200 will extend out fromreflector unit 300. In some embodiments, a distal portion of print head200, which may include nozzle 210, is positioned below reflector unit300.

In another embodiments, reflector unit 300 may be positioned adjacent toprint head 200 and thus not require openings 308, 310, and 312. In suchan embodiment, print head 200 does not pass through reflector unit 300.In some embodiments, there may be one or more reflector unit 300 and thereflector units 300 may be positioned adjacent to print head 200. Insome embodiments comprising a plurality of reflectors 300, all reflectorunits 300 may not be active at the same time. Thus, each of thereflector units 300 can be independently controlled and independentlyoperated. For example, in an embodiment comprising two reflector units300, active heater 303 of a first reflector unit 300 may be energizedand generate heat in an active state, while a second reflector unit 300may include active heater 303 that is off and in a passive state. Insuch an example, although only the first reflector unit 300 is activelygenerating heat, both reflector units 300 are passively reflecting heattowards build plate 100.

In some embodiments, one or more active heaters 303 can becommunicatively coupled to control system 50 for selectively controllingthe parameters for active heater 303. As described in greater detailbelow, control system 50 may monitor and regulate the temperature andstate (on/off) of active heater 303. For example, control system 50 maysense and monitor the temperature of printed object 800 and, dependingon the sensed temperature, may energize or de-energize active heater 303to control the heat directed towards printed object 800. For example ifthe temperature of printed object 800 is above a predeterminedthreshold, control system may de-energize active heater 303 to reducethe heat directed towards printed object 800. In some embodiments,control system 50 may be used to transmit manually inputted commands andmay energize or de-energize active heater 303 in response to themanually inputted commands.

In some embodiments, reflector unit 300 may further comprise at leastone cooling device or system (not shown) for cooling reflector unit 300.In some embodiments, cooling device may be located within reflectorhousing 306. In some embodiments, cooling device may be locatedexternally on reflector housing 306. Cooling device may be configured asany known cooling device or system, such as a fan or a liquid coolingsystem. In some embodiments, cooling device may be communicativelycoupled to control system 50. In some embodiments, control system 50 mayautomatically monitor and regulate cooling device. In some embodimentscooling device may be manually controlled by instructions and inputsentered into control system 50.

FIG. 5 is a perspective view of an embodiment of the interior of housingunit 12. In some embodiments, printing device 10 may further comprise atleast one additional heat source. In some embodiments, the additionalheat source may comprise at least one infrared (IR) light 500. It willbe appreciated that IR light 500 could be replaced with any other knownand suitable source for generating heat and is not intended to be alimiting feature. In some embodiments, IR light 500 may be positionedabove build plate 100 and oriented to direct heat towards build plate100. In some embodiments, IR light 500 may be attached and/or connectedto housing unit 12. IR light 500 may be fastened to frame 14 or may be astand-alone device located within interior of housing unit 12. In someembodiments, IR lights 500 may be attached to upper assembly 201 suchthat IR lights 500 are configured to move together with print head 200and reflector unit 300. As can be seen in FIG. 5, one embodiment ofprinting device 10 comprises two opposing IR lights 500. In someembodiments, printing device 10 may comprise any number of IR lights500. In some embodiments, IR light 500 may be communicatively coupled tocontrol system 50 to selectively operate IR light 500. For example,control system 50 may be manually controlled to transition each IR light500 from an off state to an on state. Alternatively, in some embodimentsIR light 500 may be automatically controlled by control system 50 suchthat it is programmed to turn on or off based on predeterminedparameters to maintain an optimized temperature of printed object 800 onbuild plate 100.

FIG. 6 is a perspective view of a material housing 402 for printingmaterial 400 that may be used with printing device 10. Printing device10 may be compatible with numerous printing materials including but notlimited to high-performance polymers, such as PEEK, PAEK, PEKK, and/orcombinations thereof. In some embodiments, printing material 400 may bein a filament form. Printing material 400 may comprise a range ofdiameters such as about 1 mm to about 5 mm in diameter.

In some embodiments, the printing material 400 may be implantable gradepoly ether ketone rod stock, such as Vestakeep® i-Grade materials,Vestakeep® i4 R, or Vestakeep® i4 G resin. In some embodiments, theprinting material 400 may be any medical grade FDA-approved material. Insome embodiments, the printing material 400 may have a diameter of about6-20 mm, about 25-60 mm or about 70-100 mm and a length of about 3000mm, about 2000 mm, or about 1000 mm. In some embodiments, the printingmaterial may be provided on a spool and have a length of about 60 mm or160 mm and a diameter of about 1.75 mm. Printing material may bebiocompatible, bistable, radiolucent, and sterilizable.

In some embodiments, printing material 400 may be housed in a materialhousing 402, which may be in the form of a spool, cylinder, or othersuitable enclosure for the printing material 400. In one embodiment,material housing 402 can be a cylindrical housing unit comprising afilament spool 404 for rotatably receiving printing material 400 in arotating manner. Spool has a central core 410 and side wall 412 forreceiving the printing material 400 therebetween and a top cover 414. Insome embodiments, printing material 400 may be wound around the centralcore 410 in a concentric manner.

In one embodiment, material housing 402 may be coupled to housing unit12 by being mounted on frame 14. In one embodiment, material housing 402may be coupled to one of the panels 16. In some embodiments, materialhousing 402 may be externally located, such as for example on a surfacenear printing device 10. In one embodiment, material housing 402 may belocated on top of housing unit 12, either internally or externally. Insome embodiments, material housing 402 can protect printing materialfrom damage and heat. In some embodiments, material housing 402 may alsohelp control the input of printing material 400 and prevent printingmaterial 400 from unrolling on its own.

A distal end of the filament of printing material 400 extends from thematerial housing 402 to be receiving into feed tube 212 of print head200. Printing material 400 can be conveyed to print head 200 by way of atransport device 406. Transport device 406 can provide a mechanicalmeans for unspooling or otherwise transferring printing material 400from material housing 402 to feed tube 212. In some embodiments,printing material 400 is conveyed to print head 200 via transport device406 while printing material 400 is in a solid state. In someembodiments, transport device 406 may be configured as a mechanicalextruder. Transport device 406 may have at least one operating state,for dispensing printing material 400 from material housing 402 to feedtube 212. The rate at which printing material 400 may be dispensed maybe selectively controlled by control system 50. In some embodiments,printing material 400 may be dispensed at a rate of about 2 mm to about20 mm per second. In some embodiments, printing material 400 may bedispensed at a faster or slower rate, which may vary during operation asdesired. In some embodiments, transport device 406 may further becoupled to an extruder assembly 408. In some embodiments, extruderassembly 408 may comprise a motor, planetary gear, and extruder toprovide a forward drive element to transport device 406 for feedingprinting material 400 from material housing 402 to feed tube 212.Extruder assembly 408 can aid in ensuring that printing material 400 isfed to print head 200 in a consistent and reliable manner. Furthermore,extruder assembly 408 can aid in dispensing printing material 400consistently and achieving a stable build during printing.

In some embodiments, printing device 10 may further include one or moretemperature sensors for measuring the temperature within housing unit 12at multiple locations. For example, sensor 510 may measure thetemperature of build plate 100, sensor 244 may measure the temperatureof printing material 400 within print head 200, sensor 242 may measurethe temperature of nozzle 210 of print head 200. Sensors may be locatedat a plurality of positions within the interior of housing unit 12. Insome embodiments, sensors may be located within build plate 100, printhead 200, and/or reflector unit 300. Alternatively, in some embodiments,sensors may be located externally on build plate 100, print head 200,and/or reflector unit 300. In some embodiments, sensors may be used tomeasure the temperature of various elements in printing device 10. Forexample, sensors may be used to measure the temperature of printingmaterial 400 at various points in the process, such as prior to reachingprint head 200, at the print head 200, while printing material 400 isbeing dispensed, and after printing material 400 is received on topbuild layer 110. In some embodiments, sensors 510, 242, 244 may bethermistors or thermocouples. In some embodiments, sensors may becommunicatively coupled to control system 50. For example, sensors couldbe used to measure the temperature of the current layer being printed ofprinted object 800 during printing. The measured temperature may then betransmitted to control system 50 and may be shown on display 52.

In some embodiments, printing device 10 may further comprise one or morecooling devices (not shown). In some embodiments, cooling devices may beone or more fans positioned within the interior of housing unit 12. Insome embodiments, fans may be directionally oriented such that airflowmay be directed towards build plate 100 and the printed object 800,thereby selectively cooling only build plate 100 and/or the printedobject 800. Alternatively, in some embodiments, fans may bedirectionally oriented and positioned to direct airflow throughout theinterior of housing unit 12, thereby providing ambient cooling ofinterior of housing unit 12, rather than specific cooling of selectedlocations. In some embodiments, cooling devices may comprise tubinglocated within housing unit 12 for liquid cooling. In some embodiments,tubing may be positioned at various points within housing unit 12, andmay be used for cooling build plate 100, print head 200, reflector unit300, and/or for cooling the interior of housing unit 12 generally.Tubing may be configured to receive water, liquid nitrogen, ethyleneglycol/water mixture, propylene glycol/water mixture, or any otherliquids that may be used in liquid cooling systems. In some embodiments,cooling devices may be communicatively coupled to control system 50.Control system 50 may be programmed to automatically control coolingdevices and/or cooling devices may be manually controlled byinstructions inputted into control system 50.

FIG. 7 illustrates an exemplary computer hardware system 700, that maycooperate with printing device 10 and control system 50. Computingdevice 702 can be a desktop computer, a laptop computer, a servercomputer, a mobile device such as a smartphone or tablet, or any otherform factor of general- or special-purpose computing device. Depictedwith computing device 702 are several components, for illustrativepurposes. In some embodiments, certain components may be arrangeddifferently or absent. Additional components may also be present.Included in computing device 702 is system bus 704, whereby othercomponents of computing device 702 can communicate with each other. Incertain embodiments, there may be multiple busses or components maycommunicate with each other directly. Connected to system bus 704 iscentral processing unit (CPU) 706. Also attached to system bus 704 areone or more random-access memory (RAM) modules 708.

Also attached to system bus 704 is graphics card 710. In someembodiments, graphics card 710 may not be a physically separate card,but rather may be integrated into the motherboard or the CPU 706. Insome embodiments, graphics card 710 has a separate graphics-processingunit (GPU) 712, which can be used for graphics processing or for generalpurpose computing (GPGPU). Also on graphics card 710 is GPU memory 714.Connected (directly or indirectly) to graphics card 710 is computerdisplay 716 for user interaction. In some embodiments no display ispresent, while in others it is integrated into computing device 702.Similarly, peripherals such as keyboard 718 and mouse 720 are connectedto system bus 704. Like computer display 716, these peripherals may beintegrated into computing device 702 or absent. Also connected to systembus 704 is local storage 722, which may be any form of computer-readablemedia and may be internally installed in computing device 702 orexternally and removably attached.

Finally, network interface card (NIC) 724 is also attached to system bus704 and allows computing device 702 to communicate over a network suchas network 726. NIC 724 can be any form of network interface known inthe art, such as Ethernet, ATM, fiber, Bluetooth, or Wi-Fi (i.e., theIEEE 802.11 family of standards). NIC 724 connects computing device 702to local network 726, which may also include one or more othercomputers, such as computer 728, and network storage, such as data store730. Local network 726 is in turn connected to Internet 732, whichconnects many networks such as local network 726, remote network 734 ordirectly attached computers such as computer 736. In some embodiments,computing device 702 can itself be directly connected to Internet 732.

The computer program of embodiments of the invention comprises aplurality of code segments executable by a computing device forperforming the steps of various methods of the invention. The steps ofthe method may be performed in the order discussed, or they may beperformed in a different order, unless otherwise expressly stated.Furthermore, some steps may be performed concurrently as opposed tosequentially. Also, some steps may be optional. The computer program mayalso execute additional steps not described herein. The computerprogram, system, and method of embodiments of the invention may beimplemented in hardware, software, firmware, or combinations thereof,which broadly comprises server devices, computing devices, and acommunications network.

The computer program of embodiments of the invention may be responsiveto user input. As defined herein user input may be received from avariety of computing devices including but not limited to the following:desktops, laptops, calculators, telephones, smartphones, smart watches,in-car computers, camera systems, or tablets. The computing devices mayreceive user input from a variety of sources including but not limitedto the following: keyboards, keypads, mice, trackpads, trackballs,pen-input devices, printers, scanners, facsimile, touchscreens, networktransmissions, verbal/vocal commands, gestures, button presses or thelike.

The monitor, server devices, and computing devices 702 may include anydevice, component, or equipment with a processing element and associatedmemory elements. The processing element may implement operating systems,and may be capable of executing the computer program, which is alsogenerally known as instructions, commands, software code, executables,applications (“apps”), and the like. The processing element may includeprocessors, microprocessors, microcontrollers, field programmable gatearrays, and the like, or combinations thereof. The memory elements maybe capable of storing or retaining the computer program and may alsostore data, typically binary data, including text, databases, graphics,audio, video, combinations thereof, and the like. The memory elementsmay also be known as a “computer-readable storage medium” and mayinclude random access memory (RAM), read only memory (ROM), flash drivememory, floppy disks, hard disk drives, optical storage media such ascompact discs (CDs or CDROMs), digital video disc (DVD), and the like,or combinations thereof. In addition to these memory elements, theserver devices may further include file stores comprising a plurality ofhard disk drives, network attached storage, or a separate storagenetwork.

The computing devices may specifically include mobile communicationdevices (including wireless devices), workstations, desktop computers,laptop computers, palmtop computers, tablet computers, portable digitalassistants (PDA), smartphones, and the like, or combinations thereof.Various embodiments of the computing device may also include voicecommunication devices, such as cell phones and/or smartphones. Inpreferred embodiments, the computing device will have an electronicdisplay operable to display visual graphics, images, text, etc. Incertain embodiments, the computer program facilitates interaction andcommunication through a graphical user interface (GUI) that is displayedvia the electronic display. The GUI enables the user to interact withthe electronic display by touching or pointing at display areas toprovide information to the monitor.

The communications network may be wired or wireless and may includeservers, routers, switches, wireless receivers and transmitters, and thelike, as well as electrically conductive cables or optical cables. Thecommunications network may also include local, metro, or wide areanetworks, as well as the Internet, or other cloud networks. Furthermore,the communications network may include cellular or mobile phonenetworks, as well as landline phone networks, public switched telephonenetworks, fiber optic networks, or the like.

The computer program may run on computing devices or, alternatively, mayrun on one or more server devices. In certain embodiments of theinvention, the computer program may be embodied in a stand-alonecomputer program (i.e., an “app”) downloaded on a user's computingdevice or in a web-accessible program that is accessible by the user'scomputing device via the communications network. As used herein, thestand-alone computer program or web-accessible program provides userswith access to an electronic resource from which the users can interactwith various embodiments of the invention.

In some embodiments, prior to the printing process, the object datacorresponding to an object 800 to be printed can be transmitted tocontrol system 50, which may cooperate with or include computing device702. In some embodiments, the object data may be transmitted to controlsystem 50 in file formats such as .stl, obj. or .amf, or any other fileformat created by a computer-aided design (CAD) program or software. Insome embodiments, the object data may include the geometry of the object800 to be printed as well as additional information such as tolerances,expansions, strength properties, etc. Subsequently, the CAD data may bedivided up into individual layers, such as by means of a slicer programor software. Accordingly, the slicer software may transform the 3D modelof the CAD software into a readable format for control system 50. Inthis regard, division into layers can take place both externally and inprinting device 10 itself. In some embodiments, before the printingprocess, a shrinkage process of the printed object during cooling aftera printing process may be calculated. The print routine of theindividual layers can be translated into machine readable code andtransmitted to control system 50. In some embodiments, the software ofcontrol system 50 can be a web-based application. In some embodiments,the software of control system 50 can be a computer-based softwareprogram.

In some embodiments, the object data transmitted to printing device 10may be a generic, or otherwise non-custom designs for objects 800. Suchdesigns may be useful for mass production products or when the printedobject 800 will be repeatedly printed. In some embodiments, the objectdata may be for creating a specific, custom, or one-of-a-kind object,wherein the printed object 800 will be a uniquely designed.

For example, in some embodiments, printing device 10 may be used toprint objects 800 such as medical devices or surgical implants,including spinal implants, maxillo-facial implants, ankle or footwedges, or cranial plates. Implants that are designed to bepatient-specific and are custom-made may have increased effectiveness.Such implants may be custom designed and configured to match the anatomyof a specific patient and may be configured to be printed on-site.Computer modeling may be used for obtaining three-dimensional images ofthe specific patient's anatomy through the use of MRI or CT scans, anddesigns, parameters, and other object data information may beconstructed and designed using various CAD programs or software.Accordingly, in some embodiments, the object data may comprise uniqueand patient specific instructions for printing a patient-specific object800, such as a surgical implant.

FIG. 8A illustrates an exemplary embodiment of a printed object 800 thatmay be printed using a FFF process with printing device 10. Printedobject 800 may comprise a medical implant 802, a raft 816, and ascaffolding 818. Implant 802 may comprise a plurality of layers 804, afirst porous region 806, a second porous region 808 having a latticework structure 810, and a void 812. Raft 816 may be a printed structure,printed directly on top build layer 110 and which acts as a barrierbetween direct contact of medical implant 802 and top build layer 110.Raft 816 may further reduce or limit the frequency of warping orcrystallization of medical implant 802. Raft 816 creates an interfacebetween the implant and the top build layer 110. Raft 816 is composed ofthe same material as the implant 800. In some embodiments, raft 816 maybe composed of about three printed layers on top of one another. Theprinting material in the raft 816 may be loosely spaced and is simply toprovide structure to build the implant 802 upon.

As described in greater detail below, printed object 800 may furthercomprise a scaffolding 818. In some embodiments, scaffolding 818 may beused to create a level build plane for medical implant 802, such thatwhen each layer of the plurality of layers 804 is printed, printingmaterial 400 is dispensed on a generally horizonal and level plane.Scaffolding 818 may be broken away once the implant 802 is finished andready for use. In some embodiments, the scaffolding 818 may be have aslanted top surface, such as when it is desired for the bottom surfaceof the implant 802 to be tapered. The top surface of the scaffolding 818may be slanted at a particular angle, such as 7 degrees to about 45degrees, however any angle may be used as desired. Thus, the orientationof the implant 802 may change based on the shape of the scaffolding 818.

In some embodiments and as described in greater detail below, a testcircle 814 may be printed prior to printing printed object 800 to ensurethat printing material 400 is being dispensed at the correct consistencyand flow rate. After receiving the object data of a printed object 800,printing device 10 may begin the printing process. As stated above,printing device 10 may be used in a variety of additive manufacturingprocesses including without limitation FFF printing.

FIG. 9 illustrates one embodiment of a method 900 of using printingdevice 10 to print printed object 800. A first step in method 900 maycomprise a power up 902 and review step. Power up 902 may comprisediagnostics of control system 50 and the user interface, web-basedapplication, or program, ensuring that control system 50 is workingproperly. Power up 902 may further include a review of a network statusof control system 50, a review of lower drive train 124 and upper drivetrain 280, and a review of an ambient temperature within housing unit12.

A second step of method 900 may further include a build prep 904 step.For example, during build prep 904 a cleaner may be used to clean topbuild layer 110 of build plate 100 in order to prepare the surface oftop build layer 110 to receive printing material 400. In someembodiments, the cleaner may be an acetone cleaner. Build prep 904 mayfurther include wiping top build layer 110 with a lint-free cloth andisopropyl alcohol.

A third step of method 900 may include a nozzle prep 906 step. Duringnozzle prep 906, print head 200 may be inspected and reviewed to ensurethat it is prepared for printing. For example, during nozzle prep 906feed tube 212 may be inspected for debris or other blockages, such asleftover printing filament 400 from a previous printing. For example, inan embodiment in which printing filament 400 is comprised as PEEK, printhead 200 may be heated to about 350° C. to melt any leftover PEEK thatmay be blocking feed tube 212. Print head 200 may further be cleanedwith a cleaner, such as a cotton swab.

A fourth step of method 900 may include a filament prep 908 step. Insome embodiments, printing material 400 may comprise a material that iseither dangerous to touch with a bare hand or would otherwise loseeffectiveness is touched by a bare hand. Therefore, it may beadvantageous to load printing material 400 into material housing 402using nitrile, or other sterile gloves. Printing filament 400 may thenbe partially unspooled, or otherwise fed into transport device 406. Insome embodiments, there may be printing material 400 that is at leastpartially exposed to air, or otherwise not contained within materialhousing 402. The exposed printing material 400 may further be cleaned,wiped, or otherwise prepped with isopropyl alcohol or another cleaner,to aid in maintaining purity of printing material prior to printing.During filament prep 908, printing material 400 may be cut to apredetermined length.

A fifth step of method 900 may include a build plate prep 910 step. Insome embodiments, build plate 100 may be pre-heated to a predeterminedtemperature. In some embodiments, the predetermined temperature may bebased on the specific composition of printing material. For example, insome embodiments, printing material 400 may comprise a PEEK filament,printed using a FFF method of additive manufacturing. In such anembodiment, build plate 100 can be preheated to about 145° C.Pre-heating build plate 100 to about 145° C. can help to prevent warpageof top build layer 110 and/or help prevent crystallization of printedobject 800 during printing. Build plate 100 may alternatively bepre-heated to a range of temperatures, depending on the embodiment andthe composition of printing material 400. In some embodiments, buildplate 100 may be preheated to a temperature of about 50° C. to about350° C. It will be appreciated that depending on the embodiment, buildplate 100 may be pre-heated to any temperature required for additivemanufacturing. Build plate may be pre-heated using the heating layer106, the reflector unit 300, and/or the IR lights 500.

A sixth step of method 900 may include a heating print head 912 step. Insome embodiments, print head 200 may be pre-heated to a temperature thatis hot enough to melt printing material 400, and transition printingfilament 400 from a solid state to a liquid or molten state. Forexample, in some embodiments, printing material 400 may comprise a PEEKmaterial and print head 200 may be pre-heated to about 450° C. to meltthe PEEK for dispensing. In some embodiments, print head 200 may beheated to a temperature that transitions printing filament 400 from asolid state to a glossy state, whereby print head 200 can be heated to atemperature that is able to maintain printing material 400 at or near aglass transition state.

A seventh step of method 900 may include priming filament 914. Duringpriming filament 914, a pre-determined amount of printing material 400can be transported from material housing 402 to feed tube 212 anddispensed out from nozzle 210 onto top build layer 110. In someembodiments, the predetermined amount of material 400 may be dispensedout into a test circle 814, for example, or as a line or other shape.Test circle 814 may be used as a test to determine whether the flow anddispensing of printing material is at an acceptable level, ensuring thatthe flow of printing material 400 is even and at a desired dispensingspeed.

An eighth step of method 900 may include an object print process 916step. During object print process, lower drive train 124, upper drivetrain 280, build plate 100, print head 200, reflector unit 300, IRlights 500, sensors 242, 244, 510, and any other component of printingdevice 10 that is communicatively coupled to control system 50 can becontrolled by control system 50. The temperature of print head 200, thetemperature of printing material 400, the position of build plate 100,and other pertinent parameters can be displayed on display 52 duringobject print process 916. During object print process 916, object datafor a specific printed object 800 can be selected and uploaded ortransmitted to control system 50, whereby the design, parameters, andother information comprising the object data may be used for mapping orsetting the printing pattern of printed object 800. As discussed ingreater detail below, in some embodiments G-code or software executed bycontrol system 50 can break down a 3-D model of printed object 800 intoslices or a plurality of layers, wherein a printing pattern can beimplemented for each slice or layer.

During object print process 916, printing material 400 may becontinuously fed through feed tube 212 and continuously dispensed fromnozzle 210. The rate at which printing material 400 is fed through feedtube 212 and dispensed from nozzle 210 may be monitored and regulated bycontrol system 50. Accordingly, control system 50 may be used toincrease or decrease the rate at with dispensing material 400 is fedthrough feed tube 212. It will be appreciated that during object printprocess 916, the rate at which printing material 400 is fed through feedtube 212 or dispensed from nozzle 210 may fluctuate. In someembodiments, as printing material 400 is fed through feed tube 212 andreaches heater 206, printing material 400 may be heated and melted sothat it can be dispensed out from nozzle 210. After melting, printingmaterial 400 can then be dispensed from nozzle 210 onto the pre-heatedtop build layer 110.

In some embodiments, printing material 400 may be used to print a raft816 on top build layer 110, prior to printing implant 802. Raft 816 maybe printed on top build layer 110 and act as either a stabilizer, bufferlayer, or protection layer providing a barrier between printed implant802 and top build layer 110, preventing direct contact between printedimplant 802 and top build layer 110. Accordingly, raft 816 may comprisea dimension that is larger than the dimensions of printed implant 802,wherein raft 816 prevents any direct contact between printed implant 802and top build layer 110. Raft 816 may have a surface that is larger thanthe surface of printed object 800, wherein printed implant 802 isprinted entirely on the surface of raft 816 and does not come intocontact with top build layer 110. In some embodiments, raft 816 maycomprise a generally elliptical shape. In some embodiments raft 816 maycomprise any geometric shape, and for example, may be circular,triangular, rectangular, pentagonal, or any polygonal shape. In someembodiments, printed implant 802 may be printed directly on raft 816rather than on top build layer 110. In some embodiments, raft 816 may beremoved from printed implant 802 after object print process 916 has beencompleted. For example, in some embodiments raft 816 may only berequired only during object print process 916.

In some embodiments, printing material 400 may be used to printscaffolding 818, prior to printing implant 802. Scaffolding 818 may beused to print a leveling plane or structure to aid in maintainingprinted implant 802 at a level, or approximately horizontal build-plane.For example, in some embodiments printed implant 802 may be printedhaving a varying angle or approximation of the angle of each layer ofthe plurality of build layers. Accordingly, scaffolding 818 may beprinted and comprise a plurality of layers comprising different levelsor angles wherein implant 802 may be printed upon. The levels or anglesof scaffolding 818 may be used to provide a structure or base levelwherein each layer of implant 802 may be printed at an approximatelyhorizontal plane. Scaffolding 818 may be particularly advantageous whenimplant 802 comprises a slanted or angled design, wherein each layer ofimplant 802 may be printed at approximately a horizontal level or plane.Scaffolding 818 may comprise a plurality of layers, depending on theembodiment, to provide a level build plane for implant 802. Theplurality of layers of scaffolding 818 may comprise varying heights ordimensions, depending on the dimensions and final height of implant 802.The dimensions of scaffolding 818 may vary, and in some embodiments mayhave a dimension that is larger than the dimensions of implant 802.Alternatively, in some embodiments the dimensions of scaffolding 818 mayhave be equal to the dimensions of implant 802. Alternatively, in someembodiments the dimensions of scaffolding 818 may be smaller than thedimensions of implant 802.

Thus, an exemplary object print process 916 may comprise printing raft816 on top of the build plate 100, printing a scaffolding 818 on top ofthe raft 816, and printing the implant 802 on top of the scaffolding818. Furthermore, implant 802 may be printed in a plurality of layers,with each layer being completed before the next layer is begun. Forexample, in some embodiments a first printed layer may be printed in apre-determined pattern, thickness, or other parameters. In someembodiments, a first layer of implant 802 may be printed in its entiretybefore moving up in the z-plane and printing of a second layer begins.In some embodiments, printing material 400 can be contiguously dispensedfrom nozzle 210, wherein implant 802 comprises a near constant orcontiguous composition, void of gaps, breaks, or spaces in the dispensedprinting material. Alternatively, in some embodiments printing material400 can be dispensed as droplets or in an otherwise non-contiguous flowfrom nozzle 210.

In some embodiments, after a first layer has been completed, a secondlayer of implant 802 can begin to be printed. In some embodiments, buildplate 100 may be moved down in the z-plane via lower drive train 124,moving top build layer 110 and partially printed implant 802 furtheraway from print head 200. Accordingly, as implant 802 is moved away fromprint head 200, printing material 400 can be dispensed on top of theprinted first layer. In some embodiments build plate 100 may remainstatic and print head 200 may be moved directionally in the z-plane. Forexample, after dispensing a first layer of printed object 800, upperdrive train 280 can be used to directionally move print head 200 up inthe z-plane, further away from build plate 100. In some embodiments,either or both of build plate 100 and print head 200 may bedirectionally moved in the z-plane during printing.

An exemplary method for forming a porous surgical device by contiguousdeposition may include providing a printing material 400 comprised of afilament material and forming a first layer of the surgical device bydepositing the printing material 400 on a top surface of a build plate100. Forming the first layer may include the step of extruding theprinting material through a nozzle 210 beginning at a first X-Y positionrelative to the top surface of the build plate, wherein the first layeris formed by depositing the printing material 400 in a substantiallycontiguous pattern to form at least a first region of the poroussurgical device, wherein the first region has a first porosity. Afurther step comprises forming a second layer of the surgical device bymoving the print head 200 in a Z-plane to a second Z-plane position andextruding the printing material 400 through the nozzle 210 beginning ata second X-Y position relative to the top surface of the build plate100, wherein the second X-Y position is a predetermined distance orangle from the first X-Y position. Additional layers may be formed bymoving the nozzle head in the Z-plane relative to a prior Z-planeposition, extruding the printing material 400 through the nozzle 210beginning at an X-Y position relative to the surface of the build plate100, wherein the X-Y position for any one of the plurality of layers isa predetermined distance or angle from any prior X-Y position. Any oneof the plurality of layers may have a region having a porosity that issmaller or larger than any prior-formed layer. Additionally, theporosity of each layer may vary within the layer itself.

In some embodiments, it may be advantageous or necessary to heat printedobject 800 during object print process 916. For example, in someembodiments printing material 400 may consist of a filament material,such as PEEK, PAEK, or PEKK for example. In some embodiments, printingmaterial 400 may be prone to crystallization, warping, or otherproblematic instances caused by the temperature within housing unit 12being too low or too high. Therefore, it can be advantageous to maintaina temperature range within housing unit 12 that will prevent or limitthe frequency of printing material 400 crystalizing or warping. Forexample, prior to dispensing printing filament 400, top build layer 110may be preheated to about 140° C. to about 160° C., and the temperaturemay be maintained during the entirety of object print process 916.Sensors 510 located internally within build plate 100 or sensors locatedexternally to build plate 100 may measure the temperature of top buildlayer 110, and control system 50 may actively monitor and regulate thetemperature of top build layer 110. The heat generated from build plate100 and subsequent heating of top build layer 110 can provide heat toprinted object 800. The generated heat can aid in preventingcrystallization or warping of printed object 800 during object printprocess.

In some embodiments, heat generated by reflector unit 300 can furtheraid in preventing crystallization or warping. During object printprocess 916, sensors located within housing unit 12 can measure thetemperature of printed object 800, including the temperature of one ormore layers of printed object 800. It will be appreciated that in someembodiments, it may be advantageous to selectively heat printed object800 rather than creating a static heating environment within housingunit 12. For example, as each layer of printed object 800 is dispensedand formed, the temperature of each layer, or a plurality of layers, canbe measured. The measured temperature can be transmitted to controlsystem 50, whereby control system 50 can instruct active heater 303 ofreflector unit 300 to generate more or less heat to printed object 800.In some embodiments, control system 50 can further instruct IR lights500 to generate more or less heat to printed object 800. In someembodiments, it may be advantageous to keep or maintain printed object800 or its layers, near or at a glass transition state to preventcrystallization or warping and keep printed object 800 at a glossy stateduring object print process 916. Therefore, control system 50 cancontinually monitor the temperature of printed object 800 or its layersand maintain the temperature by sending instructions to reflector unit300 and/or IR lights 500. In some embodiments, as printed object 800 ismoved further away from reflector unit 300 and/or IR lights 500 may beenergized at a higher level to increase the generated heat directed toprinted object 800. It will be further appreciated that in addition to,or alternatively as a sole means of temperature control, reflector unit300 and bottom surface 314 may also reflect heat generated from heatinglayer 106 back towards printed object 800. Accordingly, it will beappreciated that during object print process 916 printed object 800 maybe heated from below by heating layer 106 of build plate 100 and/or fromabove by reflector unit 300 (either actively through active heater 303or passively by reflective bottom surface 314) and/or IR lights 500.

In some embodiments, control system 50 can monitor the temperature ofprinted object 800 during object print process 916, and through theheating elements withing housing unit 12, can maintain a pre-determinedtemperature of printed object 800. For example, in some embodimentsprinting material 400 may comprise a PEEK filament. It may be determinedthat a printed object 800 made from PEEK filament is required to bemaintained within a range of about 140° to about 160° C. during objectprint process 916. Sensors within housing unit 12 may measure thetemperature of printed object 800 and transmit that information tocontrol system 50, which can further send instructions to active heatingelements (active heater 303, heating layer 106, IR lights 500) withinhousing unit 12 to maintain the temperature of printed object 800 withinthe determined range. For example, as printed object 800 is movedfurther away from print head 200 as object print process 916 progresses,control system 50 may send instructions to active heater 303 to energizeand direct more heat to printed object 800.

In some embodiments, the thickness of the dispensed printing material400 may be controlled by the rate at which printing material 400 isdispensed from print head 200. For example, in some embodiments, thethickness of the dispensed printing material 400 can inverselycorresponded to the flow rate at which printing material 400 isdispensed. Thus, the bead of printing material 400 dispensed at 10 mmper second will be thinner than a bead of printing material 400dispensed at 8 mm per second. In some embodiments, the flow rate anddispensing speed of printing material 400 can be selectively controlledby control system 50 and in accordance with the object data.

In some embodiments, the thickness of the dispensed printing material400 may be controlled by the rate at which build plate 100 is moved inthe x-y plane. For example, in some embodiments, if the flow rate ofprinting material 400 is kept constant, the thickness of the dispensedprinting material 400 can inversely correspond to the acceleration ordeceleration of build plate 100 in the x-y plane. Thus, the bead ofprinting material 400 dispensed on build plate 100 moving at 12 mm persecond will be thinner than a bead of printing material 400 dispensed onbuild plate 100 moving at 8 mm per second. In some embodiments, theacceleration or deceleration of build plate 100 in the x-y plane can beselectively controlled by control system 50 and in accordance with theobject data.

In some embodiments, the flow rate of printing material 400 dispensedfrom print head 200 may be synchronized with the rate at which buildplate 100 is moved in the x plane and/or y plane. For example, in someembodiments, printing material 400 may be dispensed at a constant rateto achieve a constant and uniform bead thickness and build plate 100 maybe moved in the x-y plane at the same speed that printing material 400is dispensed from print head 200. For example, in some embodiments, ifprinting material 400 is dispensed at 10 mm per second, a consistent anduniform bead thickness can be achieved if build plate 100 is moved inthe x-y plane at 10 mm per second. In some embodiments, there may bevariance between the flow rate of printing material 400 dispensed fromprint head 200 and the speed that build plate 100 is moved in the xplane and/or the y plane. For example, in some embodiments the variancebetween the flow rate of the printing material 400 and the speed ofbuild plate 100 may vary in increments of about 2 mm/second. Forexample, if printing material 400 is dispensed at a constant rate of 10mm/second, to achieve a thicker bead size, build plate 100 may be movedat about 8 mm/second in the x-y plane. Conversely, if printing material400 is dispensed at a constant rate of 10 mm/second, to achieve athinner bead size, build plate 100 may be moved at about 12 mm/second inthe x-y plane. Alternatively, the same effect may be achieved by movingbuild plate 100 at a constant speed in the x-y plane and varying theflow rate of printing material 400.

It will be appreciated that the flow rate and dispensing speed ofprinting material 400 may fluctuate or vary during object print process916. For example, in some embodiments, printed object 800 may compriselayers or sections of varying thicknesses or sizes, requiring multiplessizes and thicknesses of dispensed printing material 400. Accordingly,the flow rate and dispense rate of printing material 400 may beregulated so that printing material 400 is dispensed at the correct sizeand thickness at the correct position.

A ninth step of method 900 may comprise an end object print process 918.For example, after the final layer of printed object 800 has beendispensed, printed object 800 may be removed from top build layer 110.In some embodiments, after removing printed object 800 from top buildlayer 110, raft 816 may be removed from printed implant 802. In someembodiments, scaffolding 818 may also be removed from implant 802. Asdescribed in greater detail herein, after removing scaffolding 818and/or raft 816, implant 802 may be cleaned or sterilized.

A tenth step of method 900 may comprise a power down and cooldown 920step. During power down and cooldown 920, heating element 114, heater206, active heater 303, IR lights 500, and/or any other heated componentof printing device 10 may be turned off and cooling may begin. Thetemperature of printing device 10 and the various heating elements maybe monitored by sensors and control system 50. In some embodiments powerdown and cooldown 920 may be expedited by one or more coolers, such asfans or liquid coolers.

An eleventh step of method 900 may comprise a filament store 922 step.Any excess printing material 400 may be removed from material housing402 and stored in a storage unit (not shown). In some embodiments,printing material 400 may comprise a material that is either dangerousto touch with a bare hand or would otherwise lose effectiveness iftouched by bare hands. Therefore, it may be advantageous to removeprinting material 400 from material housing 402 using nitrile, or othersterile gloves. Printing material 400 may be stored in a dry storageunit to prevent moisture or other contamination, which may limit theeffectiveness of printing material 400 for future uses.

A twelfth step of method 900 may comprise a shut down 924 step. Duringshut down 924, control system 50 may be turned off or shut down.Printing device 10 may further be power downed or shut off. This mayinclude unplugging printing device 10 from a power source or removing abattery or other energy source from printing device 10.

With respect to FIGS. 8A-8E, in some embodiments, printing device 10 maybe used to print or create printed objects 800 having one or more porousregions, each having a different porosity. For example, FIG. 8Aillustrates one embodiment of printed object 800, where printed object800 comprises a medical implant 802. Implant 802 is composed of aplurality of layers 804 that create at least a first porous region 806and a second porous region 808. It will be appreciated that in alternateembodiments, medical implant 802 may comprise one, two, or moredifferent porous regions. In some embodiments, medical implant 802 maybe a patient-specific or custom-made implant, that is designed for aspecific patient and modeled on that particular patient's anatomy usingcomputer-aided design software. Alternatively, in some embodimentsmedical implant 802 may comprise a generic design that is not custom orpatient-specific. While references herein refer to printed object 800 asa medical implant, it will be appreciated that printing device 10 is notintended to be limited to printing objects for use in the medical orsurgical field. Accordingly, printing device 10 may be used to print orconstruct any type of object 800 that can be formed through additivemanufacturing.

In some embodiments, medical implant 802 may comprise a plurality oflayers 804, wherein each layer within the plurality of layers 804comprises both a first porous region 806 and a second porous region 808.In some embodiments, medical implant 802 may be printed layer-by-layer,wherein the entirety of one layer is printed prior to starting printingof the next layer. This process can be repeated until each layer hasbeen printed and medical implant 802 is completely formed.

In some embodiments, after the object data of medical implant 802 isuploaded to control system 50, a three-dimensional model of medicalimplant 802 may be mapped by control system 50, which may be programmedwith a G-code or other software, and a printing pattern may beimplemented. For example, in some embodiments the three-dimensionalmodel of medical implant 802 may be broken down or paired down to aplurality of layers or slices, thereby transitioning thethree-dimensional model into a two-dimensional representation of whatthe printing footprint will comprise. For example, a 3-D model ofmedical implant 802, or any other object, may be uploaded to controlsystem 50. Starting from the top of the 3-D model, the G-code orsoftware can begin breaking or pairing down the 3-D model into slices orlayers. In some embodiments, the slices may be about 50 μm to about 250μm in thickness, and may depend on the printing material used. TheG-code or software can then map or design a printing pattern fordepositing printing material 400 for ultimately forming medical implant802. In some embodiments, the G-code or software can further set ordefine the outer boundary or perimeter 844. During printing, printingmaterial 400 may be deposited in the pattern mapped out by the G-code orsoftware. In some embodiments, the G-code or software can further map ordesign the location of first porous region 806 and/or second porousregion 808. In some embodiments, the printing pattern or porosity may bealtered between each slice, providing for multiple printing patterns andporosities within the fully formed medical implant 802.

FIG. 8B illustrates an exemplary embodiment of a first layer 840 of theplurality of layers 804. As illustrated, in some embodiments, firstlayer 840 may be formed from printing material 400 that is dispensed ina wave, zigzag, serpentine, curved, or other pattern. In someembodiments, printing material 400 may be dispensed in a singularstraight-line pattern. FIG. 8B illustrates an exemplary embodiment offirst layer 840 wherein printing material is dispensed in a wave-likesinusoidal pattern 842. As seen in FIG. 8B, in some embodiments, wavepattern 842 may be dispensed in a near contiguous or continuous manner.As such, printing material 400 may be dispensed from print head 200 at asubstantially continuous or contiguous rate. For example, when printingmaterial is dispensed 400, it can be dispensed nearly continuously toavoid gaps, breaks, or an otherwise disruption of dispensing.Accordingly, wave pattern 842 can comprise a generally contiguous andsolid bead of printing material 400, absent any breaks or gaps. In someembodiments, printing material 400 can be dispensed beginning at a firstx-y position, relative to top build layer 110. Printing material 400 canbe contiguously dispensed in wave pattern 842 and moved in the x-y planeuntil reaching a predetermined perimeter 844 defining the outerdimension of medical implant 802. In some embodiments, upon reachingperimeter 844, print head 200 can be moved in the x-y plane and continuedepositing printing material in wave pattern 842 back in the directiontowards the interior of medical implant 802 until reaching perimeter 844again. In some embodiments, there may be a multiple gaps 846 or spacesbetween printing material 400 deposited in wave pattern 842. Forexample, in some embodiments gaps 846 may be about 300 μm. In someembodiments, gaps 846 may be selected from a range of about 50 μm toabout 500 μm. As further illustrated in FIG. 8B, printing material 400may be contiguously deposited in wave pattern 842, turning back to theinterior each time perimeter 844 is reached until first layer 840 iscompleted. Upon completion of first layer 840, depositing of secondlayer 850 may begin. In some embodiments, printing material 400 may becontiguously printed after each layer is completed, such that there isno gap or space of printing material between each layer, resulting in acontiguous or nearly contiguous medical implant 802. For example, aftercompleting first layer 840, depositing of second layer 850 may beginwithout stopping the feed of printing material 400 through feed tube 212from nozzle 210.

FIG. 8C illustrates second layer 850 deposited on top of first layer840, as illustrated in FIG. 8B. In some embodiments, the G-code orsoftware programming can rotate the layout or orientation of wavepattern 842. For example, in some embodiments, second layer 850 isdeposited on top of first layer 840 in wave pattern 842 in the samedesign as present in first layer 840. However, the pattern can berotated at a predetermined angle or degree, whereby printing material400 is not deposited in the exact same layout, and instead, there is acrisscrossing effect of printing material 400 between first layer 840and second layer 850. For example, FIG. 8C illustrates an embodiment inwhich the printing pattern is rotated about 36° for printing secondlayer 850 after first layer 840 is completed. In FIG. 8C, wave pattern842 in second layer 850 comprises the same design as wave pattern 842 offirst layer 840, but due to the pattern rotation, printing material 400is deposited in a resultant crisscrossing manner.

In some embodiments, the process of rotating the print pattern aftercompletion of a build layer of medical implant 802 can be repeated forall layers. In some embodiments, the pattern may be rotated a differentamount at different layers. In some embodiments, the pattern may not berotated for all layers, but rather may be rotated after a number ofsuccessive layers. The pattern may be rotated at any predetermineddegree, such as within the range of about 1° to about 179°. In someembodiments, the pattern will be rotated at the chosen degree aftercompletion of each layer that is printed. For example, in someembodiments after each layer is completed the pattern will rotate 36°degrees. Furthermore, while the pattern is rotated by control system 50via the G-code or other software, neither print head 200 nor build plate100 needs to be physically rotated. The pattern is rotated solely withinthe software programming, modifying the angle or direction with whichthe pattern is dispensed. While build plate 100 and print head 200 maybe configured to be directionally movable, neither is required to bemechanically rotated during the printing process.

FIG. 8D illustrates an exemplary embodiment of a medical implant 1000,detailing a first porous region 1002 and a second porous region 1006.FIG. 8E illustrates a cross-section of medical implant 1000. In someembodiments, medical implant 1000 may comprise at least a first porousregion 1002 having a first porosity and a second porous region 1006having a second porosity. In some embodiments, medical implant 1000 maycomprise more or less than two porous regions and may comprise anynumber of porous regions having various porosity. In some embodiments,medical implant 1000 may comprise a plurality of layers 1010. In someembodiments, medical implant 1000 may be printed layer-by-layer, whereinthe entirety of one layer is printed prior to starting printing of thenext layer. This process can be repeated until each layer has beenprinted and medical implant 1000 is completely formed. In someembodiments, each layer within the plurality of layers 1010 can comprisea first porous region 1002 and a second porous region 1006.

As illustrated in FIGS. 8D-E, in some embodiments, first porous region1002 may comprise a lattice framework or structure 1004 or otherwisecomprise a general structure having defined openings, holes, or spacingthroughout the entirety of first porous region 1002. In someembodiments, the lattice framework 1004 comprising first porous region1002 may comprise pores of about 300 mm to about 350 mm. In someembodiments, first porous region 1002 may comprise pores of about 50 mmto about 500 mm in size. In some embodiments, first porous region 1002may comprise pores of varying and non-uniform sizes.

As further illustrated in FIGS. 8D-8E, in some embodiments second porousregion 1006 may comprise a substantially solid structure 1008, havingminimal pores, openings, or gaps. Second porous region 1006 may beprinted with the same printing material 400 as first porous region 1002or may be printed using a different printing material. In someembodiments, second porous region 1006 may comprise a density havingminimal or no pores, openings, or gaps. In some embodiments, secondporous region 1006 may be formed or printed using an alternative ordifferent pattern than first porous region 1002. For example, in someembodiments second porous region 1006 may be printed using a solid beadof printing material laid in a seam-to-seam manner, resulting in asubstantially or completely solid structure. In some embodiments, secondporous region 1006 may act as a structural support, aiding inmaintaining the structural stability of medical implant 1000.

In some embodiments, the porosity of first porous region 1002 and secondporous region 1006 can be predetermined and selectively positioned. Forexample, in some embodiments medical implant 1000 is a custom, surgicalimplant designed to be anatomically compatible with a specific patient.Accordingly, it may be advantageous to selectively position a firstporous region 1002 in a certain design, shape, configuration, orlocation that will promote bone growth. Additionally, second porousregion 1006 may also be selectively positioned, ensuring that it ispositioned in a location and comprises a porosity that supports any loadbearing on medical implant 1000.

As described above, the thickness of the bead of dispensed printingmaterial 400 can be dependent on the flow rate of printing material 400from print head 200. Generally, when printing material 400 is dispensedat a faster rate, the bead will be thinner in diameter than whenprinting material 400 is dispensed at a slower rate. Accordingly, insome embodiments the flow rate can be selectively programmed orcontrolled to correspond to the predetermined porosity of sections ofobject 1000. For example, in some embodiments, the printed material 400in first porous region 1002 may have a predetermined diameter of about300 nm to about 350 nm. When dispensing material that will comprisefirst porous region 1002, printing material 400 may be dispensed at aflow rate of about 10 mm/second. In some embodiments, the printedmaterial 400 in second porous region 1006 may have a predetermineddiameter of about 500 nm to about 700 nm. When dispensing material thatwill comprise second porous region 1006, printing material may bedispensed at a flow rate of about 5 mm/second.

As further illustrated in FIG. 8E, in some embodiments, medical implant1000 may further comprise at least one overlap area 1012 where firstporous region 1002 and second porous region 1006 can interconnect. Forexample, during the printing process, when printing material 400 isdispensed to print first porous region 1002, printing material 400 mayintentionally extend beyond the boundary of first porous region 1002into the boundary of second porous region 1006. Accordingly, as eachlayer of medical implant 1000 is printed, overlap area 1012 can alsocomprise a plurality of interconnected layers, wherein first porousregion 1002 and second porous region 1006 continuously interconnect.Overlap area 1012 and the interconnection of first porous region 1002with second porous region 1006 may result in a more structurally stablemedical implant 1000. For example, after the printing process has beencompleted, and medical implant begins to harden, first porous region1002 and second porous region 1006 can harden together in aninterconnected manner, thereby strengthening the coupling between firstporous region 1002 and second porous region 1006.

Using the printing device 10, a user can print an implant 1000 on-sitefor a patient. Additional embodiments of objects to be printed aredescribed with respect to FIGS. 10, 11, 12 and 13A-E. Specifically,exemplary medical implants 2000, 3000, 4000 are described below.

FIG. 10 shows an anterior cervical interbody cage 2000 that can beprinted using the printing device 10. A cervical interbody cage 2000 isdesigned to support cervical loads while maximizing the surface areabetween the implant and the vertebral bodies it is in contact with.Cervical interbody cage 2000 is configured to be placed between a firstvertebral body and a second vertebral body in a spinal disc space in ananterior cervical interbody fusion (ACIF) procedure. Cervical interbodycage 2000 has a top surface 2002, a bottom surface 2004, an anteriorside 2008, a posterior side 2006, and peripheral sides 2007 and 2009.Cervical interbody cage 2000 may include a central opening 2010 thatextends from the top surface 2002 to the bottom surface 2004. In someembodiments, the central opening 2010 may be substantially rectangular,square, circular, oval, or any other desired shape. The central opening2010 may be configured to receive bone graft material therein forstimulating bone growth in situ.

In some embodiments, the top surface 2002 may be slanted at an angle ofabout 0-30 degrees, angled from anterior side 2008 towards posteriorside 2006. In some embodiments, the bottom surface 2004 may be slantedat an angle of about 0-30 degrees, angled from anterior side 2008towards posterior side 2006. In some embodiments, cervical interbodycage 2000 has a width of about 12-20 mm and a length of about 11-15 mm,and a height of about 5-14 mm.

In some embodiments, the anterior side 2008 may include one or moreperipheral openings 2005 therein for receiving a distal end of aninstrument for implantation. In some embodiments, one or more peripheralopenings 2005 may be internally threaded to cooperate with a distal endof an instrument. In some embodiments, one or more peripheral openings2005 may be circular. In some embodiments, peripheral sides 2007 and/or2009 may have openings (not shown) that act as graft windows. However,due to the porous structure of the cervical interbody cage 2000, graftwindows in the peripheral sides 2007, 2009 may be unnecessary. In someembodiments, the peripheral openings, or any other openings, may beadded after the cervical interbody cage 2000 is printed.

Cervical interbody cage 2000 may be designed to have a plurality ofdifferent porous regions. The porosity may be carefully balanced toprovide for structural integrity while also providing for optimal bonefixation. For example, the top surface 2002 and the bottom surface 2004may have the greatest porosity in the implant 2000. In some embodiments,the top surface 2002 and the bottom surface 2004 may have pores of about300-350 μm. A first region of porosity 2012 may extend down from the topsurface 2002 about 1-1.5 mm into the implant 2000. A second region ofporosity 2014 may extend up from the bottom surface 2004 about 1-1.5 mminto the implant 2000. It has been found that bony ingrowth maygenerally extend into an implant about 1-1.5 mm from the adjacent bonesurface. A third region of porosity 2016 may extend into the center ofthe implant 2000 between the first region 2012 and the second region2014. In some embodiments, a fourth region of porosity 2018 may extendaround a periphery of the implant, forming a less porous outerperipheral surface, as seen in FIG. 10. In some embodiments, the fourthregion 2018 may have such a small porosity such that it appears solid oralmost solid.

FIG. 11 shows an exemplary lumbar spine cage 3000 that can be printedusing the printing device 10. A lumbar spinal cage 3000 is designed tosupport lumbar loads while maximizing the surface area between theimplant and the vertebral bodies it is in contact with. Lumbar spinalcage 3000 is configured to be placed between a first vertebral body anda second vertebral body in a spinal disc space in a posterior lumbarinterbody fusion (PLIF) procedure. In one embodiment, first vertebralbody may be L4 and second vertebral body may be L5. In anotherembodiment, first vertebral body may be L5 and second vertebral body maybe S1. In some embodiments, two lumbar spinal cages 3000 may beimplanted in the same disc space.

Lumbar spinal cage 3000 has a top surface 3002, a bottom surface 3004,an anterior side 3008, a posterior side 3006, and peripheral sides 3007and 3009. Lumbar spinal cage 3000 may include a central opening 3010that extends from the top surface 3002 to the bottom surface 3004. Insome embodiments, the central opening 3010 may be substantiallyrectangular, square, circular, oval, or any other desired shape. Thecentral opening 3010 may be configured to receive bone graft materialtherein for stimulating bone growth in situ.

In some embodiments, lumbar spinal cage 3000 may be substantiallyrectangularly shaped. In some embodiments, anterior side 3008 andposterior side 3006 are shorter, and peripheral sides 3007, 3009 arelonger. In such embodiments, central opening 3010 may also besubstantially rectangularly shaped. In some embodiments, top surface3002 and/or bottom surface 3004 may be substantially planar. In someembodiments, top surface 3002 and/or bottom surface 3004 may besubstantially convex such that the center has a slightly larger heightfor engaging the adjacent bones. In some embodiments, lumbar spinal cage3000 has a width of about 8-12 mm and a length of about 20-40 mm, and aheight of about 6-16 mm.

In some embodiments, anterior side 3008 may be shaped to have asubstantially triangular-shaped bulleted tip. In some embodiments, theposterior side 3006 may include one or more peripheral openings 3005therein for receiving a distal end of an instrument for implantation. Insome embodiments, one or more peripheral openings 3005 may be internallythreaded to cooperate with a distal end of an instrument. In someembodiments, one or more peripheral openings may be circular. In someembodiments, peripheral sides 3007 and/or 3009 may have openings (notshown) that act as graft windows. However, due to the porous structureof the lumbar spinal cage 3000, graft windows in the peripheral sides3007, 3009 may be unnecessary. In some embodiments, the peripheralopenings, or any other openings, may be added after the lumbar spinalcage 3000 is printed.

Lumbar spinal cage 3000 may be designed to have a plurality of differentporous regions. The porosity may be carefully balanced to provide forstructural integrity while also providing for optimal bone fixation. Forexample, the top surface 3002 and the bottom surface 3004 may have thegreatest porosity in the implant 3000. In some embodiments, the topsurface 3002 and the bottom surface 3004 may have pores of about 100-500μm. A first region of porosity 3012 may extend down from the top surface3002 about 1-1.5 mm into the implant 3000. A second region of porosity3014 may extend up from the bottom surface 3004 about 1-1.5 mm into theimplant 3000. It has been found that bony ingrowth may generally extendinto an implant about 1-1.5 mm from the adjacent bone surface. A thirdregion of porosity 3016 may extend into the center of the implant 3000between the first region 3012 and the second region 3014. In someembodiments, a fourth region of porosity 3018 may extend around at leasta portion of the periphery of the implant, forming a less porous outerperipheral surface. In some embodiments, the fourth region 3018 may havesuch a small porosity such that it appears solid or almost solid. Insome embodiments, the fourth region is primarily on the anterior side3008 and the posterior side 3006, as seen in FIG. 11.

FIG. 12 shows an exemplary lumbar spine cage 4000 that can be printedusing the printing device 10. A lumbar spinal cage 4000 is designed tosupport lumbar loads while maximizing the surface area between theimplant and the vertebral bodies it is in contact with. Lumbar spinalcage 4000 is configured to be placed between a first vertebral body anda second vertebral body in a spinal disc space in a transforaminallumbar interbody fusion (TLIF) procedure. In one embodiment, firstvertebral body may be L4 and second vertebral body may be L5. In anotherembodiment, first vertebral body may be L5 and second vertebral body maybe S1. In some embodiments, one lumbar spinal cage 4000 is implanted inthe intervertebral space.

Lumbar spinal cage 4000 has a top surface 4002, a bottom surface 4004,an anterior side 4008, a posterior side 4006, and peripheral sides 4007and 4009. Lumbar spinal cage 4000 may include a central opening 4010that extends from the top surface 4002 to the bottom surface 4004. Insome embodiments, the central opening 4010 may be substantiallyrectangular, square, circular, oval, or any other desired shape. Thecentral opening 4010 may be configured to receive bone graft materialtherein for stimulating bone growth in situ.

In some embodiments, lumbar spinal cage 4000 may form a substantiallycurved rectangular shape. In some embodiments, anterior side 4008 andposterior side 4006 are shorter, and peripheral sides 4007, 4009 arelonger. In such embodiments, central opening 4010 may be substantiallycurved and substantially rectangularly shaped. In some embodiments, topsurface 4002 and/or bottom surface 4004 may be substantially planar. Insome embodiments, top surface 4002 and/or bottom surface 4004 may besubstantially convex such that the center has a slightly larger heightfor engaging the adjacent bones. In some embodiments, lumbar spinal cage4000 has a width of about 8-14 mm and a length of about 28-34 mm, and aheight of about 6-16 mm.

In some embodiments, anterior side 4008 may be shaped to have asubstantially triangular-shaped bulleted tip. In some embodiments, theposterior side 4006 may include one or more peripheral openings 4005therein for receiving a distal end of an instrument for implantation. Insome embodiments, one or more peripheral openings 4005 may be internallythreaded to cooperate with a distal end of an instrument. In someembodiments, one or more peripheral openings may be circular. In someembodiments, peripheral sides 4007 and/or 4009 may have openings (notshown) that act as graft windows. However, due to the porous structureof the lumbar spinal cage 3000, graft windows in the peripheral sides4007, 4009 may be unnecessary. In some embodiments, the peripheralopenings, or any other openings, may be added after the lumbar spinalcage 4000 is printed.

Lumbar spinal cage 4000 may be designed to have a plurality of differentporous regions. The porosity may be carefully balanced to provide forstructural integrity while also providing for optimal bone fixation. Forexample, the top surface 4002 and the bottom surface 4004 may have thegreatest porosity in the implant 4000. In some embodiments, the topsurface 4002 and the bottom surface 4004 may have pores of about 100-500μm. A first region of porosity 4012 may extend down from the top surface4002 about 1-1.5 mm into the implant 3000. A second region of porosity4014 may extend up from the bottom surface 4004 about 1-1.5 mm into theimplant 4000. It has been found that bony ingrowth may generally extendinto an implant about 1-1.5 mm from the adjacent bone surface. A thirdregion of porosity 4016 may extend into the center of the implant 4000between the first region 4012 and the second region 4014. In someembodiments, a fourth region of porosity 4018 may extend around at leasta portion of the periphery of the implant, forming a less porous outerperipheral surface. In some embodiments, the fourth region 4018 may havesuch a small porosity such that it appears solid or almost solid. Insome embodiments, the fourth region 4018 is primarily on the anteriorside 4008 and the posterior side 4006, as seen in FIG. 12.

In some embodiments, implants 1000, 2000, 3000, or 4000 may include acoating on the outer surfaces thereof. In some embodiments, the coatingmay include a titanium plasma spray coating and/or a hydroxyapatite (HA)coating. In some embodiments, the coating may be a HA^(nano)Suface®coating, such as manufactured by Promimic. In some embodiments, thecoating may be on the outer surfaces and/or may extend into the poresthroughout the implant, such as when the implant 1000, 2000, 3000, or4000 is dipped into a solution for coating.

In some embodiments, the implants 1000, 2000, 3000, or 4000 may includeradiopaque markers to optimize visibility and placement. In someembodiments, the radiopaque markers may be tantalum.

In some embodiments, a portion of an implant may be printed on orattached to a secondary material for providing greater structuralintegrity. Secondary material may be a metal, such as stainless steel ortitanium. In some embodiments, the secondary material may form ascaffold for receiving the printing material 400 thereon.

Further to the process as described above, in one embodiment, beforeprinting, a polymeric filament 400 may be dried in a dehydratorovernight. Then the spool 404 having filament 400 thereon is insertedinto a material housing 402, and attached to the printing device 10. Thepolymeric filament 400 is then fed into a transport device 406, whichmay be a tube running from the housing 402 to the print head 200. Thenozzle 210 is heated to the desired melt temperature for the material400. In some embodiments, the desired melt temperature is about 420° C.to about 450° C. In order to purge the line, about 50 mm of material 400may be extruded to provide a consistent flow. The build plate 100 isthen heated to the desired temperature. In some embodiments, the buildplate 100 temperature is about 140° C. to about 160° C. A program isthen selected and the object 800 is printed, as described above. Afterthe printing is completed, the raft 816 is removed from the build plate100. Then the implant 802 is removed from the raft 816 and thescaffolding 818. A knife may be used to remove any excess material.

FIGS. 13A-E shows additional exemplary embodiments of implants that maybe printed. Implants may be printed for use in a patient, such as in thespine, an extremity, or the skull. Exemplary implants may be cranialplates, maxillo-facial implants, osteotomy wedges, spinal spacers orcages, or screws or fasteners.

In some embodiments, after printing an annealing process is thenconducted. Annealing of the polymeric material is done to relieve theinternal stresses introduced during fabrication. The polymeric materialis heated to a temperature that is below the glass transitiontemperature such that the polymer chains are excited and realign. Forexample, the implant 1000, 2000, 3000, or 4000 may be placed in the ovenfor about 6 hours. In some embodiments, the annealing process may rampup for the first hour to a temperature of about 150° C., remain at thistemperature for about 1 hour, ramp up to about 200° C. over about 30minutes, remain at about 200° C. for about 1 hour, decrease to about150° C. over about 30 minutes, remain at about 150° C. for about 30minutes, and decrease to room temperature (about 20° C.). In someembodiments, the annealing process may be done at a higher temperature,such as about 300° C. when larger printed structures are involved.

In some embodiments, the implant 1000, 2000, 3000, or 4000 is left inthe oven overnight so that the implant 1000, 2000, 3000, or 4000 hastime to cool to room temperature before being removed. In someembodiments, about fifty implants 1000, 2000, 3000, or 4000 can beplaced in the oven at the same time.

The implant 1000, 2000, 3000, or 4000 can then be cleaned. For example,the implant 1000, 2000, 3000, or 400 may be placed in a heatedultrasonic cleaner with a cleaning solution for about 30 minutes. Theimplant 1000, 2000, 3000, or 4000 may then be placed in an unheatedultrasonic cleaner with a solution of water and isopropyl alcohol.

After the annealing process, any post-machining is done on the implant1000, 2000, 3000, or 4000. Post-machining may include, for example,adding holes or threading to the implant 1000, 2000, 3000, or 4000. Theimplant 1000, 2000, 3000, or 4000 may then undergo a cleaning processwhere any external debris is removed.

The implant 1000, 2000, 3000, or 4000 may be placed in a hypercleanenvironment for the application of a coating. The implant may besubmerged in a hydroxyapatite (HA) solution so that all surfaces arecoated with HA. In some embodiments, the coating may be as thin as ananometer. Due to the fully porous structure of the implant 1000, 2000,3000, or 4000, the HA coating may extend through the internal porousstructure of the device. The use of a HA coating on the implant 1000,2000, 3000, or 4000 creates a hydrophilic surface and promotes fasterosseointegration. The full porosity encourages new bone on-growth andin-growth of the implant leading to greater integration strength. Theimplant 1000, 2000, 3000, or 4000 may be heated after coating/dipping toevaporate any excess coating material. The implant 1000, 2000, 3000, or4000 may then be placed in sterile packaging and undergo gamma radiationfor sterilization.

Features described above as well as those claimed below may be combinedin various ways without departing from the scope thereof. the followingexamples illustrate some possible, non-limiting combinations:

(A1) A printing device for forming a surgical implant from a firstmaterial comprising: a housing forming an enclosed space, a print head,a planar heated build plate having a top surface for receiving the firstmaterial thereon, and a reflective plate. The print head comprises aheated nozzle for extruding the first material. The reflective platecomprises an active heating element, said reflective plate is locatedadjacent to the heated nozzle and has a bottom surface configured toreflect heat towards the build plate. The reflective unit, the heatedbuild plate, and the heated nozzle are all configured to maintain thefirst material at a predetermined temperature while forming the surgicalimplant.

(A2) For the printing device denoted as (A1), the heated build platecomprises: a top build layer comprising the top surface; a top framelayer beneath the top build layer; a heating layer comprising aresistant heater beneath the top frame layer; an insulating layerbeneath the heating layer; and a bottom frame layer.

(A3) For the printing device denoted as (A2), further comprising anintermediate layer between the heating layer and the top frame layer,wherein the intermediate layer aids in heat dissipation.

(A4) For the printing device denoted as (A2) through (A3), the top layercomprises polyetherimide (PEI), polyetheretherketone (PEEK),polyaryletherketone (PAEK), polyetherketoneketone (PEKK), otherthermoplastic polymers, glass, aluminum, stainless steel, other metallicalloys, or combinations thereof.

(A5) For the printing device denoted as any of (A2) through (A4),wherein at least one of the top frame layer and the bottom frame layercomprises aluminum.

(A6) For the printing device denoted as any of (A3) through (A5),wherein the intermediate layer comprises stainless steel.

(A7) For the printing device denoted as any of (A2) through (A6),wherein the insulating layer comprises mica or ceramic.

(A8) For the printing device denoted as any of (A1) through (A7),further comprising at least one infrared heater within the enclosedspace configured to direct heat to the surgical implant during printing.

(A9) For the printing device denoted as any of (A1) through (A8),comprising at least one temperature sensor.

(A10) For the printing device denoted as any of (A2) through (A9),further comprising a plurality of openings in the top build layer andthe top frame layer, wherein the plurality of openings are configured toreceive mechanical couplings therein and to aid in heat dissipation.

(A11) For the printing device denoted as any of (A1) through (A10),further comprising a control system including a processor, configured toreceive custom design parameters for forming the surgical implant.

(A12) For the printing device denoted as (A11), the design parametersinclude size, shape, and porosity.

(A13) For the printing device denoted as any of (A1) through (A12),wherein the first material is a thermoplastic polymer and thepredetermined temperature is near the glass transition temperature ofthe polymer.

(A14) For the printing device denoted as any of (A1) through (A13),wherein an inner surface of the housing comprises a thermally insulatingmaterial.

(B1) A system for 3-D printing a medical device comprising: a printingmaterial for forming the medical device and a printing device. Theprinting device comprises a housing forming an enclosed space, a printhead comprising a heated nozzle for extruding the printing material, aplanar heated build plate having a top surface for receiving the printmaterial thereon, and a reflective plate comprising an active heatingelement. The reflective plate is located adjacent to the heated nozzleand has a bottom surface configured to reflect heat towards the buildplate. The reflective unit, the build plate, and the nozzle are allconfigured to maintain the printing material at a predeterminedtemperature while forming the medical device.

(B2) For the system denoted as (B1), the build plate comprises: a topbuild layer comprising the top surface; a top frame layer beneath thetop build layer; a heating layer comprising a resistant heater beneaththe top frame layer; an insulating layer beneath the heating layer; anda bottom frame layer.

(B3) For the system denoted as (B1), further comprising an intermediatelayer between the heating layer and the top frame layer, wherein theintermediate layer aids in heat dissipation.

(B4) For the system denoted as (B2) through (B3), the top layercomprises polyetherimide (PEI), polyetheretherketone (PEEK),polyaryletherketone (PAEK), polyetherketoneketone (PEKK), otherthermoplastic polymers, glass, aluminum, stainless steel, other metallicalloys, or combinations thereof.

(B5) For the system denoted as any of (B2) through (B4), wherein atleast one of the top frame layer and the bottom frame layer comprisesaluminum.

(B6) For the system denoted as any of (B3) through (B5), wherein theintermediate layer comprises stainless steel.

(B7) For the system denoted as any of (B2) through (B6), wherein theinsulating layer comprises mica or ceramic.

(B8) For the system denoted as any of (B1) through (B7), furthercomprising at least one infrared heater within the enclosed spaceconfigured to direct heat to the surgical implant during printing.

(B9) For the system denoted as any of (B1) through (B8), comprising atleast one temperature sensor.

(B10) For the system denoted as any of (B2) through (B9), furthercomprising a plurality of openings in the top build layer and the topframe layer, wherein the plurality of openings are configured to receivemechanical couplings therein and to aid in heat dissipation.

(B11) For the system denoted as any of (B1) through (B10), furthercomprising a control system including a processor, configured to receivecustom design parameters for forming the medical device.

(B12) For the system denoted as (B11), the design parameters includesize, shape, and porosity.

(B13) For the system denoted as any of (B1) through (B12), wherein theprinting material is a thermoplastic polymer and the predeterminedtemperature is near the glass transition temperature of the polymer.

(B14) For the system denoted as any of (B1) through (B13), wherein aninner surface of the housing comprises a thermally insulating material.

(C1) A method for using a printing device to create a medical implant,the method comprising: providing a first material for printing themedical implant; providing a printing device; moving the print head andreflective plate vertically in a Z-plane; and moving the build platehorizontally in a X-plane and in a Y-plane. The printing devicecomprises a housing forming an enclosed space; a print head comprising aheated nozzle for extruding the first material; a planar heated buildplate having a top surface for receiving the first material thereon; anda reflective plate comprising an active heating element. The reflectiveplate is located adjacent to the heated nozzle and has a bottom surfaceconfigured to reflect heat towards the build plate. The reflective unit,the build plate, and the nozzle are all configured to maintain the firstmaterial at a predetermined temperature while forming the medicaldevice.

(C2) For the method denoted as (C1), further comprising: providing heatto the build plate to maintain the first material at the predeterminedtemperature.

(C3) For the method denoted as (C1) or (C2), further comprising:activating the heater in the reflective plate to maintain the firstmaterial at the predetermined temperature.

(C4) For the method denoted as any of (C1) through (C3), the printingdevice further comprises at least one temperature sensor, and the methodfurther comprising: sensing a temperature in at least one locationwithin the housing unit to maintain the first material at thepredetermined temperature.

(C5) For the method denoted as (C4), wherein the predeterminedtemperature is near the glass transition temperature of the firstmaterial.

(D1) A method for forming a porous surgical device by contiguousdeposition comprising: providing a printing material; extruding theprinting material through a nozzle head; moving the nozzle headvertically in a Z-plane; receiving the printing material on a topsurface of a build plate; moving the build plate horizontally in aX-plane and in a Y-plane; and depositing a plurality of layers of theprinting material on the build plate to form the surgical device.Depositing the plurality of layers comprises (a) depositing a firstlayer on the build plate; (b) rotating the substantially contiguouspattern by about 36°; and (c) depositing a second layer on top of thefirst layer; and repeating steps a, b, and c until a predeterminednumber of layers are formed.

(D2) For the method denoted as (D1) wherein the second layer extendsbeyond an outer perimeter of the first layer and the second layer.

(D3) For the method denoted as any of (D1) through (D2), furthercomprising: adjusting a speed at which the printing material isdispensed to control the porosity of the produced surgical device.

(D4) For the method denoted as any of (D1) through (D3), furthercomprising: heating the printing material at the nozzle to apredetermined temperature, wherein the predetermined temperature is nearthe glass transition temperature of the printing material.

(D5) For the method denoted as (D4), wherein the predeterminedtemperature of about 140° C. to about 160° C.

(D6) For the method denoted as any of (D1) through (D5), furthercomprising: maintaining the predetermined temperature of the printingmaterial on the build plate during the entire process.

(D7) For the method denoted as any of (D1) through (D6), furthercomprising: customizing the size, shape, and porosity of the implant fora particular patient.

(D8) For the method denoted as any of (D1) through (D7), the printingmaterial comprises polyether-ether-ketone (PEEK), polyaryletherketone(PAEK), polyetherketoneketone (PEKK), or other thermoplastic polymers.

(E1) A method for 3-D printing a medical implant comprising: providing aprinting material and a printing device comprising a nozzle; selecting afinal shape, size, and configuration of the printed implant; selecting afirst porosity for a first region of the implant; selecting a secondporosity for a second region of the implant; controlling a dispense rateof the printing material from the nozzle onto a build plate; monitoringa temperature of at least one portion of the printing device by at leastone temperature sensor; and adjusting the temperature of at least oneelement of the printer device to maintain the implant at a predeterminedtemperature during the entire printing process.

(E2) The method denoted as (E1), further comprising: heating the buildplate to maintain the implant at a predetermined temperature.

(E3) The method denoted as (E1) or (E2), wherein the first porosityforms a network of interconnected pores.

(E4) The method denoted as any of (E1) through (E3), wherein the secondporosity forms a substantially solid region.

(E5) The method denoted as any of (E1) through (E4), wherein theprinting material comprises polyether-ether-ketone (PEEK),polyaryletherketone (PAEK), polyetherketoneketone (PEKK), or otherthermoplastic polymers.

(F1) A method for forming a porous surgical device by contiguousdeposition comprising: forming a first layer of the surgical device bydepositing the printing material on a top surface of a build plate;forming a second layer of the surgical device by depositing the printingmaterial on top of the first layer; and forming the surgical device bycontinuing to form a plurality of layers relative to the first andsecond layers. The method may further include forming the first layer byextruding the printing material through the nozzle beginning at a firstX-Y position relative to the top surface of the build plate anddepositing the printing material in a substantially contiguous patternto form at least a first region of the porous surgical device, whereinthe first region has a first porosity. The method may further includeforming the second layer by moving the nozzle in a Z-plane to a secondZ-plane position; extruding the printing material through the nozzlebeginning at a second X-Y position relative to the top surface of thebuild plate, wherein the second X-Y position is a predetermined distanceor angle from the first X-Y position. The method may further includeforming the surgical device by continuing to form a plurality of layersrelative to the first and second layers by moving the nozzle in theX-plane relative to a prior Z-plane position, extruding the printingmaterial through the nozzle beginning at an X-Y position relative to thetop surface of the build plate, wherein the X-Y position for any one ofthe plurality of layers is a predetermined distance or angle from anyprior X-Y position. Any one of the plurality of layers has a regionhaving a second porosity that is different than a porosity of anyprior-formed layer.

(F2) The method denoted as (E1), further comprising: heating the buildplate to maintain the device at a predetermined temperature.

(F3) The method denoted as (F1) or (F2), wherein the first porosityforms a network of interconnected pores.

(F4) The method denoted as any of (F1) through (F3), wherein the secondporosity forms a substantially solid region.

(F5) The method denoted as any of (F1) through (F4), wherein theprinting material comprises polyether-ether-ketone (PEEK),polyaryletherketone (PAEK), polyetherketoneketone (PEKK), or otherthermoplastic polymers.

(G1) One or more non-transitory computer-readable media storing computerexecutable instructions that, when executed by a processor, perform amethod of three-dimensionally printing a medical implant, the methodcomprising: selecting a custom final shape of the implant based at leastin part on an anatomy of a particular patient; selecting a firstporosity for a first region and selecting a second porosity for a secondregion of the implant; providing a printing material to a nozzle of aprinting device; heating the printing material to at least a meltingtemperature; and dispensing a plurality of layers of the printingmaterial through the nozzle onto the build plate to form the implant.

(G2) For the media denoted as (G1), further comprising: controlling thenozzle to move vertically in the Z-plane.

(G3) For the media denoted as (G1) or (G2), further comprising:controlling the build plate to move horizontally in a X-plane and/or ina Y-plane.

(G4) For the media denoted as (G1) through (G3), further comprising:dispensing the printing material in a predetermined pattern and aftereach layer is completed, rotating the pattern by about 36° beforeprinting a successive layer.

(G5) For the media denoted as (G1) through (G4), further comprising:controlling heating of the build plate to maintain the implant at apredetermined temperature during the entire process.

(G6) For the media denoted as (G1) through (G5), wherein the printingmaterial comprises polyether-ether-ketone (PEEK), polyaryletherketone(PAEK), polyetherketoneketone (PEKK), or other thermoplastic polymers.

(G7) For the media denoted as (G1) through (G6), further comprising amemory for storing a library of printable designs for a plurality ofdifferent implants.

(H1) A selectively porous customizable medical implant made by theprocess of fused filament fabrication by a 3-D printer comprising: atleast a first region having a first porosity and at least a secondregion having a second porosity, wherein the pores of the first regionare larger than the pores of the second region.

(H2) For the implant as denoted by (H1), the first region has a latticestructure with interconnected pores.

(H3) For the implant as denoted by (H1) or (H2), the implant comprisespolyether-ether-ketone (PEEK), polyaryletherketone (PAEK),polyetherketoneketone (PEKK), or other thermoplastic polymers.

(H4) For the implant as denoted by (H1) through (H3), further comprisinga hydroxyapatite (HA) coating, wherein the coating extends through thepores.

(H5) For the implant as denoted by (H1) through (H4), the implant isconfigured to be used as a spinal implant, a cranial flap implant, amaxillofacial implant, or a foot or ankle wedge implant.

(H6) For the selectively porous customizable medical implant as denotedby (H1) through (H5), the pores of the first region have a pore size ofabout 300 μm.

(I1) A spinal implant formed by a polymer monofilament 3-D printingprocess, comprising: a top surface; a bottom surface; a peripheral outersurface; and a central opening; and a porous section having a pluralityof interconnected pores. The porous section has a first plurality ofopenings on the top surface and a second plurality of openings on thebottom surface. The implant shape and pore size are selectable forcustomizing the implant to a particular patient.

(I2) For the spinal implant denoted as (I1), comprising a solid sectionon the outer peripheral surface.

(I3) For the spinal implant denoted as (I1) or (I2), the porous sectioncomprises a first material, wherein the first material ispolyetheretherketone (PEEK), polyaryletherketone (PAEK),polyetherketoneketone (PEKK), or another thermoplastic polymer.

(I4) For the spinal implant denoted as any of (I2) through (I3), thesolid section comprises a second material, wherein the second materialis titanium, stainless steel, or thermoplastic polymer.

(I5) For the spinal implant denoted as any of (I1) through (I4), theimplant is formed by a contiguous deposition of a first material in aplurality of layers.

(I6) For the spinal implant denoted as any of (I1) through (I5), theporous section comprises pores having a size of about 300 μm.

(J1) A surgical implant formed by additive manufacturing comprising: aplurality of layers forming at least one region of interconnected pores,wherein the pores are configured to facilitate bone growth therein. Theimplant is customizable to the anatomy of a particular patient and isconfigured for use within the spine, an extremity, or the skull of apatient. The plurality of layers comprise a printing material depositedin a particular predetermined pattern to form the interconnected pores.

(J2) For the surgical implant denoted as (J1) the implant comprisespolyetheretherketone (PEEK), polyaryletherketone (PAEK),polyetherketoneketone (PEKK), or another thermoplastic polymer.

(J3) For the surgical implant denoted as (J1) or (J2), comprising ahydroxyapatite (HA) coating extending into the pores.

(J4) For the surgical implant denoted as any of (J1) through (J3),comprising pores having a size of about 300 μm.

Although the invention has been described with reference to theembodiments illustrated in the attached drawing figures, it is notedthat equivalents may be employed and substitutions made herein withoutdeparting from the scope of the invention as recited in the claims.

Having thus described various embodiments of the invention, what isclaimed as new and desired to be protected by Letters Patent includesthe following:
 1. A method for forming a porous surgical device bycontiguous deposition comprising: providing a print material comprisinga filament material; forming a first layer of the porous surgical deviceby depositing the print material on a top surface of a lower heatedbuild plate, wherein forming the first layer includes the step ofextruding the print material through a heated nozzle head beginning at afirst X-Y position relative to the top surface of the lower heated buildplate, wherein the first layer is formed by depositing the printmaterial in a substantially contiguous and predetermined pattern to format least a first region of the porous surgical device, wherein the firstregion has a first porosity; forming a second layer of the poroussurgical device, including the steps of: moving the heated nozzle headin a Z-plane to a second Z-plane position; extruding the print materialthrough the heated nozzle head beginning at a second X-Y positionrelative to the top surface of the lower heated build plate, wherein thesecond X-Y position is a predetermined distance or angle from the firstX-Y position, wherein the second layer is formed by depositing the printmaterial on top of the first layer in a substantially contiguous andpredetermined printing pattern; forming the porous surgical device bycontinuing to form a plurality of layers relative to the first andsecond layers, including the steps of: moving the heated nozzle head inthe Z-plane relative to a prior Z-plane position; and extruding theprint material through the heated nozzle head beginning at an X-Yposition relative to the top surface of the lower heated build plate,wherein the X-Y position for any one of the plurality of layers is apredetermined distance or angle from any prior X-Y position; repeatingdepositing a plurality of layers of the print material on the lowerheated build plate to form the porous surgical device; and maintaining apredetermined temperature of the print material on the lower heatedbuild plate during an entire printing process by using the heated nozzlehead, the lower heated build plate, and a separate upper active heatedreflector located adjacent the heated nozzle head, wherein the lowerheated build plate comprises: a top build layer comprising the topsurface; a top frame layer beneath the top build layer; a heating layercomprising a resistant heater, said heating layer beneath the top framelayer; an insulating layer beneath the heating layer; and a bottom framelayer.
 2. The method of claim 1, wherein after depositing the firstlayer and before depositing the second layer, rotating the predeterminedprinting pattern by about 36°.
 3. The method of claim 1, furthercomprising depositing the print material in a substantially contiguouspattern to form at least a second region of the porous surgical devicehaving a second porosity.
 4. The method of claim 3, wherein the firstregion extends beyond an outer perimeter of the second region tofacilitate interconnection of the first region and the second region. 5.The method of claim 1, further comprising: adjusting at least one of:(i) a speed at which the print material is dispensed or (ii) the speedat which the lower heated build plate is moved in an X-plane and aY-plane, to control the porosity of the surgical device.
 6. The methodof claim 1, further comprising: heating the print material at the heatednozzle head to a predetermined temperature of about 140° C. to about160° C.
 7. The method of claim 1, wherein the porous surgical device isa surgical implant, further comprising: customizing a size, shape, andporosity of the surgical implant for a particular patient.
 8. A methodfor 3-D printing a medical implant comprising: providing a printingmaterial and a printer device comprising a heated nozzle, a lower heatedbuild plate, and a separate upper active heated reflective elementlocated adjacent the heated nozzle; selecting a final shape, size, andconfiguration of the medical implant; selecting at least a firstporosity for a first region of the medical implant; controlling adispense rate of the printing material from the heated nozzle onto thelower heated build plate; monitoring a temperature of at least oneportion of the printer device by at least one temperature sensor; andadjusting the temperature of the heated nozzle, the lower heated buildplate, or the separate upper active heated reflective element tomaintain the medical implant at a predetermined temperature during anentire printing process, wherein the medical implant comprises a size,shape, and porosity designed for an anatomy of a particular patient,wherein the lower heated build plate comprises: a top build layercomprising the top surface; a top frame layer beneath the top buildlayer; a heating layer comprising a resistant heater, said heating layerbeneath the top frame layer; an insulating layer beneath the heatinglayer; and a bottom frame layer.
 9. The method of claim 8, furthercomprising heating the lower heated build plate to maintain the medicalimplant at the predetermined temperature.
 10. The method of claim 8,wherein the first porosity forms a network of interconnected pores. 11.The method of claim 8, further comprising selecting a second porosityfor a second region of the medical implant, wherein the second porosityforms a substantially solid region.
 12. The method of claim 8, whereinthe printing material is polyaryl-ether-ketone (PAEK).
 13. The method ofclaim 8, further comprising moving the lower heated build plate duringprinting to control the first porosity of the medical implant.